Depuy (ireland) Loughbeg, Ringaskiddy Co. Cork Ireland: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Recall Summary DePuy Synthes is recalling a specific knee prosthesis (ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM, Part Number: 150450208) because the outer sterile packaging was found stuck to the inner sterile packaging, which may have compromised the sterility of the device. The product was distributed nationwide across the United States. This is classified as a Class II recall, indicating a potential health hazard.
- Recalling firm
- DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork Ireland
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
- 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/5059c46a-342b-4ab8-ad58-827c887c1d40