Depuy (ireland): Depuy Synthes, Attune Revision Hinge Femoral Lt Sz 7 Cem. Part Number: 150450107
Recall Summary DePuy Synthes is recalling ATTUNE Revision Hinge Femoral Left Size 7 Cement surgical implants (Part Number: 150450107) 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 units distributed nationwide. The device is a knee replacement component used in orthopedic surgery.
- Recalling firm
- DEPUY (IRELAND)
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
- 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/67d381af-d679-42f9-bc35-73f88da11542