Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIOngoing
Summary: DEPUY (IRELAND) is recalling Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.. Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
What is being recalled
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Why
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of MN, NC, TX. (states named: Minnesota, North Carolina, Texas)
How to tell if yours is affected
Part Number: 150450203. UDI-DI: 10603295533146. Lot Number: 1007537. Expiration Date: 10/31/2035.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1989-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 3, 2026 |
| Reported | May 6, 2026 |
| Company | DEPUY (IRELAND) |
| Company location | Co. Cork, Ireland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 units |
More recalls from DEPUY (IRELAND) · all medical device recalls · recalls from April 2026