DEPUY (IRELAND) recalls Depuy Synthes

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1988-2026
• FDA 510(k) clearance · K242871The device's official FDA premarket clearance record
• FDA device classification · KROOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3510The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find DEPUY (IRELAND)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.