The Recall Desk
ModerateFDA (Devices)·Z-1993-2026·Announced 2026-05-06

DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern

DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is a packaging defect that potentially compromises sterility—a concern for device integrity but classified by FDA as Class II, which under the rubric corresponds to moderate severity when no adverse outcomes have been reported.

Plain-English summary

DePuy (Ireland) is recalling 3 units of the ATTUNE Revision Hinge Femoral RT SZ 8 CEM (Part Number 150450208) due to a packaging defect. The external sterile packaging was found adhered to the internal sterile packaging, which potentially compromises the sterility of the device.

This product was distributed in the United States in the states of Minnesota, North Carolina, and Texas. Lot numbers AF1008441 and AF1008028 are affected, with an expiration date of 12/31/2035.

Patients who have received or may receive this device should contact their healthcare provider or DePuy if they have any concerns about the sterility of the device or if they experience any signs of infection.

The recalled product

Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Manufacturer
DEPUY (IRELAND)
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441
  • AF1008028. Expiration Date: 12/31/2035.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 9 recalled by DEPUY (IRELAND) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · DEPUY (IRELAND)

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Same hazard · sterility compromise

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