Stryker GmbH recalls Long Nail

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

Stryker notified consignees on about 05/28/2025 via FedEx letter. Consignees were instructed to review inventory and immediately quarantine any affected units on hand, and complete and return the Business Reply Form documenting receipt and product segregation. Upon receipt of the response form, Stryker will contact consignees to arrange for return of the affected units. If affected products have been further distributed, consignees were instructed to notify those customers and let Stryker know.

• FDA enforcement recordOfficial FDA database entry for Z-1914-2025
• FDA 510(k) clearance · K213328The device's official FDA premarket clearance record
• FDA device classification · HSBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3020The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker GmbHSearch 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.