Depuy (ireland): Depuy Synthes, Attune Revision Hinge Femoral Rt Sz 3 Cem. Part Number: 150450203
Recall Summary DePuy Synthes is recalling a specific knee replacement component (ATTUNE Revision Hinge Femoral Right Size 3 Cement, Part Number 150450203) because the external sterile packaging was found stuck to the internal sterile packaging, which could compromise the sterility of the device. The product was distributed nationwide across the United States. This is a Class II recall, indicating a situation where use of the product could cause serious adverse health consequences or death.
- Recalling firm
- DEPUY (IRELAND)
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
- Reason
- The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-03
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of MN, NC, TX.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/0798b7e8-0c83-4e58-ad6c-41a9928dab92