Depuy (ireland): Depuy Synthes, Attune Revision Hinge Femoral Lt Sz 5 Cem. Part Number: 150450105
Recall Summary DePuy Synthes is recalling ATTUNE Revision Hinge Femoral Left Size 5 Cement knee implants (Part Number 150450105) because the external sterile packaging was found stuck to the internal 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, indicating a potential health risk but not an immediate life-threatening situation.
- Recalling firm
- DEPUY (IRELAND)
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
- 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/fe74321d-defa-490c-8925-35e4a860d654