Depuy (ireland): Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Recall Summary DePuy Synthes is recalling specific ATTUNE Revision Hinge Knee components because the external sterile packaging was found stuck to the internal sterile packaging, which could compromise the sterility of the product. The affected components come in multiple sizes (labeled B through X) and were distributed to medical facilities in Minnesota, North Carolina, and Texas. This is classified as a Class II recall.

Recalling firm: DEPUY (IRELAND)
Product: Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 151730012. 3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN D; Part Number: 151730014. 4. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN E; Part Number: 151730016. 5. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN F; Part Number: 151730018. 6....
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: 2026-05-19
Status: Open, Classified
Areas affected: MN, NC, TX
Distribution: Distribution to MN, NC, TX.

Recall details on Nibble Recalls: https://trynibble.app/recalls/4f360dd6-695e-4fc5-9896-2c400bc7904d