United StatesDepuy Synthes ATTUNE Revision Hinge Femoral implants (left and right sizes 3, 4, 5, 7, 8) with part numbers 150450104, 150450105, 150450107, 150450108, 150450203, 150450204, 150450205, 150450207 and 150450208, and the listed UDI‑DIs, lot numbers, and expiration dates are being recalled. The recall was issued because the external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
What's being recalled
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Recalling firm: Depuy (Ireland), Co. Cork, Ireland.
How to identify it
Part Number: 150450104. UDI-DI: 10603295533115. Lot Number: 1007844. Expiration Date: 11/30/2035 Part Number: 150450105. UDI-DI: 10603295533122. Lot Number: AF1007829. Expiration Date: 12/31/2035. Part Number: 150450107. UDI-DI: 10603295533139. Lot Number: 1006440. Expiration Date: 11/30/2035. Part Number: 150450108. UDI-DI: 10603295543022. Lot Number: AF1006441. Expiration Date: 12/31/2035. Part Number: 150450203. UDI-DI: 10603295533146. Lot Number: 1007537. Expiration Date: 10/31/2035. Part Number: 150450204. UDI-DI: 10603295533153. Lot Number: 1005229. Expiration Date: 10/31/2035. Part Number: 150450205. UDI-DI: 10603295533160. Lot Number: 1006444. Expiration Date: 10/31/2035. Part Number: 150450207. UDI-DI: 10603295533177. Lot Number: 1007046. Expiration Date: 10/31/2035. Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441, AF1008028. Expiration Date: 12/31/2035.
The hazard
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of MN, NC, TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)