Depuy (ireland): Depuy Synthes, Attune Revision Hinge Femoral Rt Sz 8 Cem. Part Number: 150450208
Recall Summary DePuy Synthes is recalling ATTUNE Revision Hinge Femoral Right Size 8 Cement (Part Number: 150450208), a knee replacement component, because the external sterile packaging was found stuck to the internal sterile packaging, which may have compromised the product's sterility. The device was distributed nationwide across the United States. This is a Class II recall, meaning there is a potential health risk but not an immediate danger to life.
- Recalling firm
- DEPUY (IRELAND)
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
- 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/0f18ec11-462d-4ffb-b349-67c7f1182abc