FDA DeviceClass IINotable

FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

Date: 2026-05-06
Brand: DEPUY (IRELAND)
Category: Medical Device
FDA Class: Class II

Description

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Hazard

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Remedy

3 units

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