FDA recall, , Moderate risk
Depuy Synthes Attune Revision Hinge Femoral
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Summary by Recall Canary from the FDA notice
What happened
DEPUY (IRELAND), of Co. Cork, Ireland, recalled Depuy Synthes ATTUNE REVISION HINGE FEMORAL products because the external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. The recall began April 3, 2026, and was added to the FDA's Enforcement Report on April 29, 2026. Distribution was in the states of MN, NC, TX.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
9 products
Affected if its UDI-DI, lot code and part code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 8 CEM.
- UDI-DI
- 150450108
- 10603295543022
- Part code
- 150450108.
- Lot code
- AF1006441
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 5 CEM.
- UDI-DI
- 150450205
- 10603295533160
- Part code
- 150450205.
- Lot code
- 1006444
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 5 CEM.
- UDI-DI
- 150450105
- 10603295533122
- Part code
- 150450105.
- Lot code
- AF1007829
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 8 CEM.
- UDI-DI
- 150450208
- 10603295543039
- Part code
- 150450208.
- Lot code
- AF1008441
- AF1008028
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 7 CEM.
- UDI-DI
- 150450107
- 10603295533139
- Part code
- 150450107.
- Lot code
- 1006440
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 3 CEM.
- UDI-DI
- 150450203
- 10603295533146
- Part code
- 150450203.
- Lot code
- 1007537
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 4 CEM.
- UDI-DI
- 150450104
- 10603295533115
- Part code
- 150450104.
- Lot code
- 1007844
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 7 CEM.
- UDI-DI
- 150450207
- 10603295533177
- Part code
- 150450207.
- Lot code
- 1007046
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 4 CEM.
- UDI-DI
- 150450204
- 10603295533153
- Part code
- 150450204.
- Lot code
- 1005229
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Minnesota, North Carolina, Texas.
- Company
- DEPUY (IRELAND)Co. Cork, Ireland
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98707
- Recall numbers
- Z-1985-2026 to Z-1993-2026
All recalls from DEPUY (IRELAND)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
