The recall affects all lots of the Rejuvenate Modular and the ABG II modular-neck hip stems.
The company initiated the recall after post-market surveillance data showed that the fretting and corrosion risk “may be predictive of a trend,” according to an FDA statement.
Hip stems are attachments to artificial hips that allow the device to better fit a patient’s anatomy.
In an FAQ release, the company noted that “patients may present with symptoms of pain and swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis.”
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