Recall Z-1989-2026— DEPUY (IRELAND)

Name: FDA recall Z-1989-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-03

Class II · Ongoing

Class II FDA medical device recall by DEPUY (IRELAND), initiated 2026-04-03. It names one FDA 510(k) clearance: K242871. Product: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.. Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility..

Recalling firm: DEPUY (IRELAND)
Classification: Class II
Status: Ongoing
Initiated: 2026-04-03
Firm location: Co. Cork, Ireland

510(k) clearances named in this recall

1 on FDA's record

K242871 — ATTUNE Revision Hinge KneeDepuy Ireland UC·cleared 2024-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.