DEPUY (IRELAND) is recalling several models of the Depuy Synthes ATTUNE REVISION HINGE FEMORAL components because the external sterile packaging was found stuck to the internal packaging. This defect may compromise the sterility of the medical device before it is used in surgery. This recall affects a total of 3 units distributed to healthcare facilities in Minnesota, North Carolina, and Texas.
If the sterile packaging is compromised, the implant may become contaminated with microorganisms, which could lead to serious infections for patients undergoing knee revision surgery.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
External sterile packaging adhered to internal sterile packaging.
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 ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.