Depuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall
Depuy Synthes is recalling 3 units of the ATTUNE Revision Hinge Femoral (Right, Size 5, Cemented) knee implant due to external sterile packaging adhered to internal sterile packaging, potentially compromising product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a sterility-barrier defect on an implantable orthopedic device. Although no reported illnesses or injuries are stated in the source, the potential compromise of sterility on a knee implant poses a significant risk of infection, meeting the High (score 3) threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Depuy (Ireland) is recalling 3 units of the ATTUNE Revision Hinge Femoral Right Size 5 Cemented knee component (Part Number 150450205, UDI-DI: 10603295533160, Lot 1006444, expiration 10/31/2035). The external sterile packaging was found adhered to the internal sterile packaging, which may have compromised the product's sterility.
The affected units were distributed nationwide to facilities in Minnesota, North Carolina, and Texas. A compromised sterile barrier on an implantable orthopedic device poses a risk of infection at the surgical site.
Patients and healthcare providers with questions should contact their respective hospitals or Depuy. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
- Manufacturer
- DEPUY (IRELAND)
- Hazard
- sterility-barrier-compromise
- infection-risk
Distribution
Distributed nationwide across the United States.
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