Depuy (ireland): Depuy Synthes, Attune Revision Hinge Femoral Rt Sz 4 Cem. Part Number: 150450204
Recall Summary DePuy Synthes is recalling ATTUNE Revision Hinge Femoral Right Size 4 Cement knee implants (Part Number 150450204) because the outer sterile packaging was stuck to the inner sterile packaging, which may have compromised the sterility of the product. This Class II recall affects devices distributed nationwide across the United States. Healthcare facilities that received these implants should check their inventory against the part number and lot numbers provided by the manufacturer.
- Recalling firm
- DEPUY (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
- U.S. Food and Drug Administration
- Recall date
- 2026-04-03
- Status
- Ongoing
- 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 U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/92160ccb-7190-4b1a-9fd9-f7c5701db75a