Smith & Nephew, Inc. is recalling 21 units of its Tandem Bipolar Hip System component, specifically the Tandem International Bipolar Cocr Shell/UHMWPE Liner with a TI-6AL-4V Retaining Ring. The recall was initiated because the assembly contains an oversized retainer ring, which can interfere with the proper function of the hip replacement system. The affected devices were manufactured in the United States and distributed to hospitals and surgical centers internationally.
The oversized retainer ring can prevent the hip component from seating or assembling correctly during surgery. This could lead to surgical delays, the need for replacement components, or potential failure of the implant if the issue is not identified before or during the procedure. No injuries or incidents have been reported to date.
Sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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