Depuy (ireland) Loughbeg, Ringaskiddy Co. Cork Ireland: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Recall Summary DePuy Synthes is recalling ATTUNE REVISION HINGE FEMORAL RIGHT SIZE 7 CEMENTED knee prostheses (Part Number: 150450207) distributed nationwide because the external sterile packaging was found stuck to the internal sterile packaging, which may have compromised the sterility of the device. This is classified as a Class II recall. The affected product was distributed across all U.S. states, with concentrated distribution in Minnesota, North Carolina, and Texas.
- Recalling firm
- DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork Ireland
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
- 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
- FDA-DEVICES
- Recall date
- 2026-04-03
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/022c3b67-bc53-49b3-a88d-89cf6d86a577