Depuy (ireland) Loughbeg, Ringaskiddy Co. Cork Ireland: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Recall Summary DePuy Synthes is recalling ATTUNE Revision Hinge Femoral Left Size 5 Cemented knee replacement prostheses (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. This is a Class II recall affecting devices distributed nationwide across the United States. The recall applies to hospitals and medical facilities that received these knee implants.
- Recalling firm
- DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork 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
- 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/91fc6895-5907-43f9-815f-f4bdebf64083