ATTUNE recallZ-1991-2026 · Depuy (Ireland) · initiated Apr 3, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Depuy (Ireland) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA root cause category: Under Investigation by firm
What the company is doing
Depuy Ireland notified consignees on about 04/03/2026 via email. Consignees were instructed to examine inventory for affected units and immediately quarantine them, arrange for the return of all affected units, and complete and return the provided Business Response Form. Consignees were also instructed to forward the notification letter to anyone within each facility that needs to be informed, notify customers if affected units were further distributed and post a copy of the notification letter in a visible area for awareness.
Recall details
- Recall number
- Z-1991-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 3, 2026
- Posted by the FDA
- Apr 29, 2026
- Recalling firm
- Depuy (Ireland)
- Quantity
- 3 units
- Product code
- KRO
- FDA submissions
- K242871
- Distribution
- US Nationwide distribution in the states of MN, NC, TX.
Product description
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Code information (models, lots, serial numbers)
Part Number: 150450205. UDI-DI: 10603295533160. Lot Number: 1006444. Expiration Date: 10/31/2035.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ATTUNE 1504-50-205Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98707).
- Z-1985-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
- Z-1986-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
- Z-1987-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
- Z-1988-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
- Z-1989-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
- Z-1990-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
- Z-1992-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
- Z-1993-2026 · Open, ClassifiedDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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