Depuy (ireland) Loughbeg, Ringaskiddy Co. Cork Ireland: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Recall Summary DePuy Synthes is recalling certain ATTUNE Revision Hinge Femoral Right Size 4 Cemented knee prostheses because the external sterile packaging was found stuck to the internal sterile packaging, which may have compromised the sterility of the device. This recall affects units distributed nationwide across the United States. This is a Class II recall, meaning there is a potential health hazard but the device is unlikely to cause serious injury or death.
- Recalling firm
- DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork Ireland
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
- 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/ab60429a-ca9b-4c06-92d2-35ab9c61e12f