Exactech, Inc. is recalling approximately 1,575 hip liners sold under the AcuMatch XLE, Novation XLE, and Alteon XLE brand names. These surgical implants were packaged without a necessary Ethylene Vinyl Alcohol (EVOH) barrier layer, which is intended to protect the plastic from oxygen. Without this barrier, the liners can undergo oxidation, causing the material to degrade and potentially fail earlier than expected. The recall affects medical devices distributed to hospitals and surgical centers across multiple states and international locations.
The lack of a proper oxygen barrier causes the polyethylene liners to oxidize, which can lead to accelerated wear and debris in the hip joint. This degradation can cause bone loss (osteolysis) and eventual implant failure, which may require complex revision surgery to correct.
Affected quantity: 42 units.
Affected quantity: 87 units.
Affected quantity: 1,446 units.
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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