Stryker GmbH: Device Recall

Recall #Z-1914-2025 · 05/28/2025

Class II: Risk

Recall Details

Recall Number: Z-1914-2025
Classification: Class II
Product Type: Device
Recalling Firm: Stryker GmbH
Status: Ongoing
Date Initiated: 05/28/2025
Location: Selzach, Switzerland
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

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

Product Description

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

Distribution Pattern

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

Other Recalls by Stryker GmbH

Class II: Risk 05/22/2025

Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Class II: Risk 05/22/2025

Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Class II: Risk 03/28/2025

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Class II: Risk 03/28/2025

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Class II: Risk 05/09/2024

The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

View all recalls by Stryker GmbH →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.