Recall Z-1914-2025— Stryker GmbH

Name: FDA recall Z-1914-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-28

Class II · Ongoing

Class II FDA medical device recall by Stryker GmbH, initiated 2025-05-28. It names one FDA 510(k) clearance: K213328. Product: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.. Reason: Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail..

Recalling firm: Stryker GmbH
Classification: Class II
Status: Ongoing
Initiated: 2025-05-28
Firm location: Selzach, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K213328 — Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH·cleared 2022-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.