Depuy (ireland) Loughbeg, Ringaskiddy Co. Cork Ireland: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Recall Summary DePuy Synthes is recalling ATTUNE REVISION HINGE FEMORAL artificial knee components (Part Number: 150450104) 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 hazard but not an immediate life-threatening situation.
- Recalling firm
- DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork 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
- 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/1b4ba3ee-8be2-4755-88ec-5596f8285111