Depuy (ireland): Depuy Synthes, Attune Revision Hinge Femoral Lt Sz 4 Cem. Part Number: 150450104
Recall Summary DePuy Synthes is recalling ATTUNE Revision Hinge Femoral Left Size 4 Cement knee implants (Part Number 150450104) because the outer sterile packaging was stuck to the inner sterile packaging, which may have compromised the sterility of the device. The affected products were distributed nationwide across the United States. This is a Class II recall, meaning the product could cause serious health consequences or death.
- Recalling firm
- DEPUY (IRELAND)
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
- 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/85d34ad6-820b-4ff6-a10c-b83681bb7c26