BioPro, Inc. is recalling 147 units of several orthopedic implant models, including Femoral, Endo, and Bipolar heads, due to a packaging issue that could compromise the sterile barrier of the device. If the sterile barrier is breached, the device may lose its sterility before it is used in surgery. These devices were distributed to medical facilities in Michigan and Texas.
A loss of device sterility presents a serious risk of infection to the patient if the device is implanted during surgery. Such infections can lead to significant health complications, prolonged recovery, or the need for additional surgical procedures.
All lots and serial numbers affected.
All lots, all serial numbers.
All lots, all serial numbers.
All lots, all serial numbers.
All lots, all serial numbers.
All lots, all serial numbers.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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