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ATTUNE Revision Hinge Femoral
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MEDICAL DEVICE RECALLMODERATE

ATTUNE Revision Hinge Femoral

Depuy Synthes recalls ATTUNE Revision Hinge Femoral over packaging adhesion that may compromise sterility.

What to do

Do not use the affected product. Contact Depuy Synthes for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-1988-2026
Agency
FDA
Firm
DEPUY (IRELAND)
Recall ID
98707
Status
ONGOING

Recall at a glance

Quantity recalled
3 units

Why it was recalled

Depuy Synthes is recalling the ATTUNE Revision Hinge Femoral Left Size 4 Cemented component because the external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL

ProductLot codeRecall #UDI-DI
LT SZ 8 CEM. Part Number: 150450108.AF1006441, 2035Z-1988-2026150450108, 10603295543022
RT SZ 5 CEM. Part Number: 150450205.1006444, 2035Z-1991-2026150450205, 10603295533160
LT SZ 5 CEM. Part Number: 150450105.AF1007829, 2035Z-1986-2026150450105, 10603295533122
RT SZ 8 CEM. Part Number: 150450208.AF1008441, AF1008028, 2035Z-1993-2026150450208, 10603295543039
LT SZ 7 CEM. Part Number: 150450107.1006440, 2035Z-1987-2026150450107, 10603295533139
RT SZ 3 CEM. Part Number: 150450203.1007537, 2035Z-1989-2026150450203, 10603295533146
LT SZ 4 CEM. Part Number: 150450104.1007844, 2035Z-1985-2026150450104, 10603295533115
RT SZ 7 CEM. Part Number: 150450207.1007046, 2035Z-1992-2026150450207, 10603295533177
RT SZ 4 CEM. Part Number: 150450204.1005229, 2035Z-1990-2026150450204, 10603295533153

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from DEPUY (IRELAND)

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification