Synthes (USA) Products LLC recalls LOW PROF LCKNG SCREW

Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

DePuy Synthes notified consignees via email and mailed letter on 09/26/2025. Consignees were instructed to examine inventory and quarantine affected units, arrange for the return of any affected units, complete and return the Business Response Form, and place the notification in a visible area for awareness. If units were further distributed within your facility or to customers, please notify those customers and personnel.

• FDA enforcement recordOfficial FDA database entry for Z-0229-2026
• FDA 510(k) clearance · K201336The device's official FDA premarket clearance record
• FDA 510(k) clearance · K201346The device's official FDA premarket clearance record
• FDA device classification · JDSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3030The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Synthes (USA) Products LLCSearch 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.