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Open, Classified

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

FDA Recall Z-1914-2025 · Posted 2025-06-06

Recalling FirmStryker GmbH
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2025-05-28

Reason for Recall

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

Firm Action

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.

Root Cause

Process design

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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