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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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)
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 9 recalled by DEPUY (IRELAND) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · DEPUY (IRELAND)
See all →- HighDePuy Synthes ATTUNE Revision Hinge Knee Components Packaging Sterility Issue
FDA (Devices) · 2026-07-08
- HighDePuy Synthes ATTUNE Revision Hinge Knee Insert Components Recall
FDA (Devices) · 2026-07-08
- HighDePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
FDA (Devices) · 2026-05-06
- ModerateDePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
FDA (Devices) · 2026-05-06
- ModerateDePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
FDA (Devices) · 2026-05-06
Same hazard · sterility barrier compromise
See all →- HighDIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility
FDA (Devices) · 2022-02-09
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