Corentec Co., LTD is recalling 432 units of the LOSPA Tibial Insert and LOSPA Patella Component because the 10-year expiration date on the labels is not supported by stability testing. These medical devices are components used in knee replacement surgeries. If used beyond their actual safe lifespan, the materials may degrade, leading to potential device failure or the need for revision surgery. These components were distributed to healthcare providers in Alabama, Arizona, California, Michigan, Pennsylvania, and Texas.
The plastic components may not maintain their integrity or sterility for the full 10-year period claimed on the package, which could lead to premature wear, breakage, or infection within the knee joint. No specific injuries have been reported, but the unsupported shelf life poses a risk to the long-term success of the implant.
Contact healthcare provider or manufacturer
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.
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Sources: FDA iRES · Raw API Response
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