Exactech, Inc. is recalling 589 AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liners because they were packaged without a necessary protective barrier layer called ethylene vinyl alcohol (EVOH). This packaging error affected products manufactured and distributed between 2004 and August 2021. The missing layer can allow oxygen to reach the device, potentially degrading the plastic liner over time. Consumers who have had hip replacement surgery involving these specific liners should contact their surgeon or healthcare provider to discuss their implant's status.
The absence of the EVOH oxygen barrier layer may lead to accelerated wear, bone loss, or component fatigue of the plastic hip liner due to oxidation. If the device fails prematurely, patients may require additional surgery to replace the damaged implant.
Patient monitoring and surgeon consultation
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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