Theken Companies LLC has issued a voluntary recall for approximately 409 units of the iNSitu Bipolar Hip System Bipolar head implants. These medical devices, used in hip replacement surgeries, failed transit testing which indicated that the sterile barrier of the packaging could be compromised. The recall affects twelve different size variants of the Bipolar Head Assembly distributed in New Jersey, Pennsylvania, and Texas.
A compromised sterile barrier can allow contaminants to enter the device packaging, which significantly increases the risk of infection or surgical complications for patients receiving the implant. No injuries or incidents have been reported to date.
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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