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Earl's View

~ News and Views

Earl's View

Tag Archives: Medical device

Half of decade-old metal hip implants defective – Life & Style – NZ Herald News

August 23, 2015

Half of decade-old metal hip implants defective – Life & Style – NZ Herald News. Half of decade-old metal hip …

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Medical device firms push to comply with new FDA rules

March 16, 2014

Source & full article: Medical device firms push to comply with new FDA rules. Medical device firms push to comply with …

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How does the FDA ‘approve’ medical products? – Medical News Today

February 22, 2014

Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …

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Biomet reaches $56 million settlement over faulty hip replacements | Reuters

February 5, 2014

Source: Biomet reaches $56 million settlement over faulty hip replacements | Reuters. Biomet reaches $56 million settlement over faulty hip replacements …

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The Myth of the Medical-Device Tax

November 15, 2013

The Myth of the Medical-Device Tax WASHINGTON — IN the last few days of negotiations in Congress, repeal of the …

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Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

November 14, 2013

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants Andrew Testa for The New York Times …

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Consumer Reports Urges a Lemon Law For Joint Replacements

October 18, 2013

Consumer Reports Urges a Lemon Law For Joint Replacements by Christy Rakoczy, a J.D. Manufacturers of hip and knee replacement …

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FiDA Failed Implant Device Alliance: Exposed! : Secret Medical Device Payments to Doctors

October 6, 2013

FiDA Failed Implant Device Alliance: Exposed! : Secret Medical Device Payments to Doctors. Exposed! : Secret Medical Device Payments to …

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ASME DC | Journal of Medical Devices | Battery-Less Wireless Instrumented Knee Implant

April 7, 2013

ASME DC | Journal of Medical Devices | Battery-Less Wireless Instrumented Knee Implant. Battery-Less Wireless Instrumented Knee Implant J. Holmberg, L. …

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FDA cracks down on all-metal hip replacements

March 4, 2013

http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html FDA cracks down on all-metal hip replacements Manufacturers who want to keep selling all-metal hips will have to prove …

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Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury

February 25, 2013

Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury. Metal hip patients ‘need annual checks’ …

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Smith & Nephew Failure Warning for Birmingham Hip Implant

February 25, 2013

Smith & Nephew Failure Warning for Birmingham Hip Implant. Smith & Nephew Failure Warning for Birmingham Hip Implant September 27, …

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The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com

February 17, 2013

The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com. Doctors Who Don’t Speak Out By BARRY MEIER Published: …

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Patients victims of untested medical devices – SFGate

February 16, 2013

Patients victims of untested medical devices – SFGate. Patients victims of untested medical devices Victoria Colliver Updated 9:21 pm, Tuesday, February …

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What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com

February 12, 2013

What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com. EDITORIAL What a Company Knew About Its Metal Hips Published: …

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A Few New Year’s Wishes and Thoughts from one of the many MOM ‘Victims’!

January 8, 2013

A Few New Year’s Wishes and Thoughts from one of the many MOM ‘Victims’! Well, 2013 is finally here, the …

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Howard Comments: Layoffs: Medical device companies cut 7,000 jobs in 2012 | MassDevice

December 25, 2012

As was anticipated big layoffs from the medical device manufacturers; the BLAME or FINGER being pointed at the device tax to …

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Metal on Metal Expert Hip Resurfacing – Tom Joyce on device regulation | BMJ

December 9, 2012

Medical devices – Tom Joyce on device regulation | BMJ. Medical devices – Tom Joyce on device regulation The BMJ …

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What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

November 11, 2012

What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass …

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Howard Says – And We Agree – Come Clean Smith & Nephew

November 1, 2012

It is time for Smith and Nephew to be realistic and honest, afterall in their code of ehtics the safety …

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Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph

October 26, 2012

Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph. Faulty medical implants investigation: Patients treated ‘like guinea pigs’ …

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Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph

October 26, 2012

Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph. Faulty medical …

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The FDA is there to protect patients? Bullsh*t …

October 11, 2012

The FDA is there to protect patients? Bullsht | MassDevice – Medical Device Industry News. The FDA is there to …

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Hundreds of NZ hip replacements are faulty – National – NZ Herald News

October 4, 2012

Hundreds of NZ hip replacements are faulty – National – NZ Herald News. Hundreds of NZ hip replacements are faulty …

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Shake-up of EU medical device regulations shocks industry

October 3, 2012

Shake-up of EU medical device regulations shocks industry. Source: http://www.buildingbetterhealthcare.co.uk/news/article_page/Shakeup_of_EU_medical_device_regulations_shocks_industry/81250  Shake-up of EU medical device regulations shocks industry Medical Devices | Market Information | Regulatory | …

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Medical Devices Vulnerable to Hacking Need Oversight – Businessweek

September 29, 2012

Medical Devices Vulnerable to Hacking Need Oversight – Businessweek. Bloomberg News Medical Devices Vulnerable to Hacking Need Oversight By Jordan …

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Australia – Sky News: Hip replacements should be checked – TGA

September 22, 2012

Sky News: Hip replacements should be checked – TGA. Hip replacements should be checked – TGA Updated: 08:07, Friday September …

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Plaintiffs look to depose new Johnson & Johnson CEO Gorsky in DePuy ASR lawsuit | MassDevice – Medical Device Industry News

September 15, 2012

Plaintiffs look to depose new Johnson & Johnson CEO Gorsky in DePuy ASR lawsuit | MassDevice – Medical Device Industry …

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New Zealand – Medical Devices – Medsafe Guidelines for MoM hips

September 14, 2012

Medical Devices. Management of Patients with Metal on Metal Hip Implants. Medsafe and the New Zealand Orthopaedic Association (NZOA) (www.NZOA.org.nz) support …

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South Africa – Sixty sue for dud hip joints – Crime & Courts | IOL News | IOL.co.za

September 14, 2012

Sixty sue for dud hip joints – Crime & Courts | IOL News | IOL.co.za. Sixty sue for dud hip …

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Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process

September 7, 2012

Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …

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Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant

August 30, 2012

Journal of Medical Case Reports | Abstract | Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant: a case …

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» Medical device units recalled in Q2 represent eight-quarter high | MedCity News

August 30, 2012

» Medical device units recalled in Q2 represent eight-quarter high | MedCity News. Medical device units recalled in Q2 represent …

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FDA Aims To Smooth Premarket Review process | Bloomberg BNA

August 24, 2012

FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …

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Cry from the Heart – Where is Mr Smith & his Nephew?

August 20, 2012

Recent comment published on Earl‘sview that deserves more notice: Does Smith and Nephew not hear the cries from victims of …

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Pre Market Approval – Why does the Law shelter Smith & Nephew & others like them?

August 20, 2012

Premarket Approval by the FDA – why do we lose out? Reading this recent law review article by Professor Ralph Hall, …

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Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney

August 19, 2012

Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney. The Smith & Nephew R3 Hip Implant …

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Dems urge FDA to boost medtech recall database | MassDevice.com

August 19, 2012

Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …

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Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes

August 18, 2012

Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …

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Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform

August 18, 2012

Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform. Rottenstein Law Group Reports on …

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The US Medical Device Market is a Dinosaur – Mike comments

August 14, 2012

The medical device industry is a dinosaur. Sales people getting paid hundreds of thousands who don’t really know anything about …

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Is the US Medical Device Industry Heading the Way of the Dinosaur?

July 21, 2012

Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …

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Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register

July 21, 2012

Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …

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FDA – Overview of Medical Device Regulation > Information about MDUFA III

July 15, 2012

Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …

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Medical Device ID Proposal Unveiled – GovInfoSecurity

July 15, 2012

Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …

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FDA to help medical device sales with expanded pre-market feedback program

July 15, 2012

FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …

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As lawsuits climb, J&J may have new hip trauma – Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending

July 14, 2012

As lawsuits climb, J&J may have new hip trauma | Smart Business. As lawsuits climb, J&J may have new hip …

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Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions

July 14, 2012

Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …

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FDA to guide device makers on marketing application – chicagotribune.com

July 14, 2012

FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …

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About Metal-on-Metal Hip Implants

July 14, 2012

About Metal-on-Metal Hip Implants. About Metal-on-Metal Hip Implants If you or your loved one has endured a MoM hip implant …

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FDA – User Fees for Medical Devices: Third Time Lucky?

July 8, 2012

User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …

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FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier

July 8, 2012

FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1

July 8, 2012

June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …

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FDA releases proposed UDI rule; reaction generally positive

July 8, 2012

FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …

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Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today

July 8, 2012

Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …

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FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments

July 8, 2012

FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …

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Smith & Nephew BHR – Food and Drug Administration, HHS

July 8, 2012

http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …

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FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…

July 7, 2012

FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr.  Roberts: Food and Drug …

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Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA

July 7, 2012

Wright Medical’s Response to Smith & Nephew‘s Response to WMT request to Deny BHR PMA http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-rc00001-01-vol3.pdf. Click the above link …

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Premarket Approval (PMA) Database – BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

July 7, 2012

MDRWeb Medical Device Register On-line from Canon Communications, LLC. Premarket Approval (PMA) Database Premarket Approval (PMA) Database Trade Name: BIRMINGHAM …

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P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices

July 7, 2012

P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices. PMA Application: P040033 S017 (Most recently approved supplement) Attribute …

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Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL

July 7, 2012

Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL Post-Approval Studies. Post-Approval Studies FDA Home Medical Devices Databases – …

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New FDA guidance on considerations used in device approval

July 7, 2012

New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …

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The US Drug Watchdog Now Urges Plaintiffs Law Firms Worldwide To Contact Them About A Possible International Effort To Help Victims Of Defective Drugs Or Medical Devices – SFGate

July 1, 2012

The US Drug Watchdog Now Urges Plaintiffs Law Firms Worldwide To Contact Them About A Possible International Effort To Help …

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Medical Device « The Senate Passes Unparalleled Medical Device User Fee Act

June 30, 2012

Medical Device « DePuy Recall Blog. The Senate Passes Unparalleled Medical Device User Fee Act When the Senate passed the resolution …

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Press release: MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice : MHRA

June 26, 2012

MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice Contact: Press Office 020 3080 …

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FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew

June 17, 2012

Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in …

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Comment Example: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

June 5, 2012

I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, …

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Thanks from Howard

June 3, 2012

Thank you Earl and your blog again and thank you  folks that have contacted me re: attorneys. I will let …

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FDA rule clears medical devices without human testing | devices, – News – The Orange County Register

May 24, 2012

FDA rule clears medical devices without human testing | devices, – News – The Orange County Register. Published: May 18, …

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Zimmer Durom Cup Hip Implant – Waters & Kraus

May 24, 2012

Zimmer Durom Cup Hip Implant – Waters & Kraus. Zimmer Durom Cup Hip Implant We protect the interests of those …

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Are Metal-on-Metal Hip Implants Tied to Increased Cancer Risk? Part Three: Specific Cancer Risks Post Metal-on-Metal Hip Implant

May 24, 2012

Are Metal-on-Metal Hip Implants Tied to Increased Cancer Risk? Part Three: Specific Cancer Risks Post Metal-on-Metal Hip Implant. Are Metal-on-Metal …

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Howard poses some important questions….

May 24, 2012

I am looking for a real answer to a real question- if the Catholic Church was held accountable for their …

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Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year | ExpertRECALL | Recall Management, Product Retrieval, Recall Logistics

May 22, 2012

Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year  Mike Rozembajgier 05-14-2012 By Mike RozembajgierMedical device …

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Corporate Whistle Blower Center Launches New Initiative to Go After a Very Corrupt US Medical Device Industry and Urges Insiders to Step Forward for Possible Huge Rewards

May 13, 2012

Corporate Whistle Blower Center Launches New Initiative to Go After a Very Corrupt US Medical Device Industry and Urges Insiders …

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German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry News

May 13, 2012

German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry …

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Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry

May 12, 2012

Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry. The global medical crises of dangerous metal-on-metal hip implants …

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Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public

May 12, 2012

Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public. Public Communication – Health Canada Issued Important Safety Information …

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Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG

May 12, 2012

Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …

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MoM Hip Victim Stories to the Orthopedic and Rehab Devices Panel of Med. Devices Advisory Commitee

May 1, 2012

I just want to emphasize how important it is for as many of us as possible to send in our …

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June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

April 27, 2012

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …

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Howard shares more views

April 25, 2012

Medical News: has 2 articles, reiteration, (daily.headlines@medpagetoday.com). People must learn about this or nothing will happen other than the medical …

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What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs

March 24, 2012

What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs. What is the Status of …

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Senators Introduce Safe Medical Devices Act

March 24, 2012

Senators Introduce Safe Medical Devices Act. Senators Introduce ‘Safe Medical Devices Act’ A bipartisan group of U.S. senators is pushing …

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FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra

March 24, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …

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Consumer Reports Poll: Consumers Support More Medical Device Oversight

March 21, 2012

Consumer Reports Poll: Consumers Support More Medical Device Oversight Posted: 20 Mar 2012 07:38 AM PDT CONSUMERS UNION NEWS RELEASE     …

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House of Representatives to take away Patients rights to Sue

March 18, 2012

March 16, 2012 Next week, the U.S. House of Representatives will be voting on H.R. No. 5, which has been …

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US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and the DePuy ASR was Just the Starting Point – Yahoo! News

March 3, 2012

US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and …

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Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA

March 1, 2012

Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA. Press release: MHRA updates advice for metal-on-metal hip replacements …

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Mark’s Story – another Smith & Nephew BHR disaster – 18 Months

January 26, 2012

Yesterday I was told the total hip resurfacing Smith and Nephew I received 9/2010 must be removed. They are doing …

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The Power of the Birmingham Hip Resurfacing – NOT

January 21, 2012

Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …

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FDA warns J&J’s DePuy unit over joint replacements – AlertNet

January 19, 2012

FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …

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More Hocus Pocus around the Smith & Nephew BHR Metallosis Problems

January 14, 2012

Correspondence from an “in pain and damaged BHR recipient” To: [deleted doctors name] Biosciences & Implants Unit Medical Devices Division …

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Mesh Medical Device Newsdesk

January 8, 2012

Mesh Medical Device Newsdesk » latest news, information and perspective from the regulatory, industry and patient point of view, something …

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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

January 7, 2012

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …

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Howards View on the FDA and Medical Device Failures

January 7, 2012

Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …

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More Smith & Nephew BHR Problems

January 2, 2012

More Smith & Nephew BHR – MoM Problems Emerging each day Comment received overnight: I too have a Smith and …

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Howard View – on a few things

December 30, 2011

Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …

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FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline

December 29, 2011

Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …

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Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record

December 28, 2011

Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record. Zimmer knee replacement manufacturer sued for metal …

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Howard’s View – Get Your Health Right is Number One Priority

December 28, 2011

More and more people are sharing their stories of suffering because of this hip debacle. This is great, let’s others …

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The regulatory standards for the approval of medical devices in Australia – Senate Inquiry

December 25, 2011

The regulatory standards for the approval of medical devices in Australia – Senate Inquiry On 16 June 2011 the Senate …

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FDA seeks to include more women in medical device trials

December 20, 2011

FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …

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Howard Sdwin: What isn’t being published is the truth regarding the medical device world

December 17, 2011

What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …

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San Francisco Personal Injury Attorney Analyzes Depuy Lawsuits And Preemption

November 26, 2011

San Francisco Personal Injury Attorney Analyzes DePuy Lawsuits And Preemption. DePuy Hip Implant Claims & Federal Preemption November 23, 2011 …

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Howard Gets A New Hip – But Still Wants Justice

November 23, 2011

For those of you who have been following this blog for some time, you will recall the story of Howard …

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MAKO aims to get hip-replacement patients back on feet faster

October 11, 2011

MAKO aims to get hip-replacement patients back on feet faster October 10, 2011 — 7:57am ET | By Liz Jones …

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Howard Sadwin’s Story – a lesson in perserverance…

September 17, 2011

Howard’s Story (as written by Howard): My intentions are to tell my story, and for others to listen to my …

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The rate at which FDA issues 483s and warning letters is going up, up, up.

August 25, 2011

The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …

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Complaints Surge About Crumbling Artificial Hips

August 24, 2011

Complaints Surge About Crumbling Artificial Hips on August 23, 2011 Source: fairwarning.org As researchers scramble to assess the health dangers of …

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FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices

August 20, 2011

FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011  Source: Medical Design Online For the first …

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IOM chair discusses 510(k) report: origins, findings, response

August 18, 2011

IOM chair discusses 510(k) report: origins, findings, response Written by Brian Dunham   August 15, 2011 Source: Cardiovascular Business David …

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FDA Loosens Premarket Notification Requirements for 30 Medical Device Types

August 15, 2011

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …

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Sadwin gets to the heart of the Issues with FDA 510(k)

August 14, 2011

Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …

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FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units

August 13, 2011

Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …

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Medical Devices — Balancing Regulation and Innovation

August 13, 2011

Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …

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IOM Gives FDA The wrong prescription on medical devices & 510(k)

August 7, 2011

  Editorial: The wrong prescription on medical devices Article by: EDITORIAL , Star Tribune Updated: August 6, 2011 – 6:19 …

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How Safe Are Medical Devices?

August 5, 2011

How Safe Are Medical Devices? Published: August 4, 2011 New York Times A prestigious medical group is concerned that most …

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Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants?

August 4, 2011

Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? Published: August 3, 2011—Shana Leonard Source: MPMN …

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FDA Seeks Public Views on Proposed 510(k) Plans

August 2, 2011

FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …

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Australian TGA – Reforms in the medical devices regulatory framework: Overview of submissions

July 31, 2011

Reforms in the medical devices regulatory framework: Overview of submissions 11 February 2011 Background On 2 November 2010, the TGA released a …

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Australian TGA – Reforms in the medical devices regulatory framework

July 31, 2011

Australian TGA – Reforms in the medical devices regulatory framework Consultation Source: TGA – Click here 2 November 2010 Relevant …

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Australian TGA Response to Recall of DePuy ASR Hip Replacement

July 31, 2011

Recall of DePuy Orthopaedics ASR hip replacement device 16 May 2011 Source Therapeutic Goods Administration Recall of DePuy Orthopaedics ASR …

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British Woman files product liability lawsuit against Wright Medical Technology

July 31, 2011

Wright Hip Replacement Lawsuit Filed by Woman from Great Britain Source: AboutlawSuites.com Published: July 29th, 2011 An U.K. woman has …

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US Congress Women Rosa L. DeLauro Takes FDA To Task Over Comments re IOM Report

July 31, 2011

For Immediate Release Friday, July 29, 2011 Contact: Kaelan Richards 202-225-3661 DELAURO TO FDA: 510(k) MEDICAL DEVICE APPROVAL PROCESS UNSAFE, …

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Report: FDA’s Medical Device Approval Process Is Flawed

July 31, 2011

Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …

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510(k) approval process is too big to fail no matter how flawed it may be

July 31, 2011

7.29.11 | Arundhati Parmar Source: MedCityNews 510(k) approval process is too big to fail no matter how flawed it may …

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U.S. advisers call for new medical device regime

July 31, 2011

U.S. advisers call for new medical device regime Andrew Seaman Reuters Full Edition July 30, 2011 WASH­INGTON (Reuters) – An …

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Barry Meier – Approval process for devices blasted

July 31, 2011

Approval process for devices blasted Barry Meier The Boston Globe July 30, 2011 The govern­ment’s system for reg­u­lating many med­ical …

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Expert group calls for new way to clear medical devices

July 31, 2011

Expert group calls for new way to clear medical devices Christine Mai-Duc | Tribune Washington Bureau Source: ongo The Tennessean …

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Sadwin Comments on Washington Post Article – Letter to Authors

July 31, 2011

Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …

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Advisory panel calls for revamping FDA approval process for medical devices

July 31, 2011

Advisory panel calls for revamping FDA approval process for medical devices David Brown and N.C. Aizenman The Washington Post Ongo.com …

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FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report

July 31, 2011

FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …

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Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process

July 31, 2011

Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …

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Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs

July 30, 2011

Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …

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Report could sway FDA device review process

July 30, 2011

Report could sway FDA device review process Source: Reuters By Andrew Seaman WASHINGTON | Tue Jul 26, 2011 1:40pm EDT (Reuters) – …

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FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process

July 30, 2011

Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …

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Barry Meier – Study Faults Approval Process for Medical Devices

July 30, 2011

Study Faults Approval Process for Medical Devices BY BARRY MEIER PUBLISHED: JULY 29, 2011 NEW YORK TIMES The government’s system for regulating …

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510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release

July 30, 2011

510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …

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Sadwin has a few other Pithy Points for the Orthopaedic “Big Guys”…

July 29, 2011

[Earl’s View] Comment: “Bruce Greenfield may be the last New Zealander implanted with a faulty hip joint “ Market share …

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Barry Meier – Study of Medical Device Rules Is Attacked, Unseen

July 29, 2011

Study of Medical Device Rules Is Attacked, Unseen By BARRY MEIER New York Times – Click here Published: July 27, 2011 Allies of …

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Can’t shoot the Messenger [Sales Rep] …

July 28, 2011

Remand Denials in Hip Implant MDL Source: click here We’ve just found out about multiple remand denials from the Depuy hip …

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Why Are Pharmaceutical Companies Paying The FDA?

July 28, 2011

Why Are Pharmaceutical Companies Paying The FDA? Posted by Amber Racine J uly 27, 2011 10:31 AM Source: Click here The FDA …

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Report: IOM review of the FDA 510(k) process due Friday

July 28, 2011

Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …

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FDA medical device review times to be subject of House hearing

July 23, 2011

FDA medical device review times to be subject of House hearing The House Energy & Commerce Committee’s oversight subcommittee is …

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Scientists push biocompatible materials for use in orthopaedic implants

July 17, 2011

Materials Research Gets Under the Skin Scientists push biocompatible materials to interact with their surroundings in intelligent ways By: Stephanie …

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Is Medical Device Design Going to the Dogs?

July 17, 2011

Is Medical Device Design Going to the Dogs? Published: May 23, 2011 The Massachusetts-based Worcester Business Journal featured an interesting …

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Roundtable: Evolution, Not Revolution, Drives Biomaterials Development

July 17, 2011

Published: Tue, Nov 30, 2010 – 11:25 am Roundtable: Evolution, Not Revolution, Drives Biomaterials Development MPMN 25th Anniversary Coverage Marcus …

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DePuy ASR Hip Implant was Untested

July 10, 2011

DePuy ASR Hip Implant was Untested Date Published: Monday, April 4th, 2011 Could the controversial recalled DePuy hip replacement devices …

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Senate Hearing on FDA Medical Device Approvals

July 10, 2011

DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …

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FDA 510K Process for Medical Devices Let Unsafe Devices Through

July 10, 2011

FDA Again Criticized for Medical Device Oversight Date Published: Wednesday, April 13th, 2011 Thousands of medical devices are approved annually …

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Swimmer Files Suit over DePuy ASR

July 10, 2011

Former Swimmer Files Suit over DePuy ASR Hip Resurfacing System Date Published: Tuesday, June 28th, 2011 A former competitive swimmer …

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Zimmer NexGen MIS Tibial Component Recall

July 8, 2011

Zimmer NexGen Component Recall The Zimmer NexGen MIS tibial component recall affected 68,384 knee components, which were distributed in 13 …

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Corin Cormet FDA Approval – At Least the FDA Panel included Metal Ion Serum Levels

July 7, 2011

Orthopaedic and Rehabilitation Devices Panel – February 22, 2007 The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Thursday, …

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Corin 510K Approval Details

July 6, 2011

Corin FDA Approvals Source: click here Corin 510K Biolox FDA Approval K103120.pdf Corin Minhip K083312.pdf Corin BIOLOX delta Modular Femoral …

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Sadwin Gives them a Sterling Suggestion or Two

July 4, 2011

Just in from Howard’s Desk (wheel chair) … I just sent a feedback message to med page. How ridiculous it …

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There are over 1,600 posts on this site - and about 30 pages too. The best way to find what you want is to type in the search box.

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  • Cyntia Morton – Emotional Fitness
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  • Metal Hip Problems in the UK – S&N Hip Problems
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  • FDA Information on Metal on Metal Hips
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Hip Info Sites

  • DePuy Hip Recall Information
  • DePuy Victims Blog – for anyone
  • Failed Implant Device Alliance
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  • Metal Hip Problems in the UK – S&N Hip Problems
  • Smith & Nephew Hip Problems – Levin Law
  • Total Hip Replacement News – Facebook Group
  • UK – Metal Hip Problems

Legal Help

  • Anapol Schwartz
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  • Bernstein Liebhard LLP
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  • Cobalt Poisoning from Medical Devices Website
  • DePuy Hip Recall Information
  • Failed Implant Device Alliance
  • Hardison & Cochran Attorneys – fiting Depuy ASR Cases
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  • Smith & Nephew Hip Problems – Levin Law
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  • Age and gender affect risk of hip replacement revision surgery | Arthritis Research UK
  • FINALLY --- New rules to end secrecy over safety of medical implants - Telegraph
  • Day 3, 4, 5 Post Revision
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