FDAClass II · Medical device · Recalled May 6, 2026

Depuy Synthes recall — DEPUY (IRELAND)

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1985-2026
Brand: DEPUY (IRELAND)
Classification: Class II
Units affected: 3 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Depuy Synthes

Companies & origin

Recalling firm location: Co. Cork, Ireland
Firm address: Loughbeg, Ringaskiddy, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Part Number: 150450104. UDI-DI: 10603295533115. Lot Number: 1007844. Expiration Date: 11/30/2035
Distribution: US Nationwide distribution in the states of MN, NC, TX.
Firm notified the public via: E-Mail
FDA event ID: 98707
Recall initiated: April 3, 2026
FDA classified: April 29, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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