Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
FDA Recall Z-1993-2026 · Posted 2026-04-29
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Recalling FirmDEPUY (IRELAND)
Recall StatusOpen, Classified
Product CodeKRO
Date Initiated2026-04-03
Product Quantity3 units
Reason for Recall
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Firm Action
Depuy Ireland notified consignees on about 04/03/2026 via email. Consignees were instructed to examine inventory for affected units and immediately quarantine them, arrange for the return of all affected units, and complete and return the provided Business Response Form. Consignees were also instructed to forward the notification letter to anyone within each facility that needs to be informed, notify customers if affected units were further distributed and post a copy of the notification letter in a visible area for awareness.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of MN, NC, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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