Stryker GmbH: Device Recall

Recall #Z-1621-2025 · 03/28/2025

Class II: Risk

Recall Details

Recall Number: Z-1621-2025
Classification: Class II
Product Type: Device
Recalling Firm: Stryker GmbH
Status: Ongoing
Date Initiated: 03/28/2025
Location: Selzach, Switzerland
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6407 units

Reason for Recall

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.

Product Description

Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

Distribution Pattern

US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

Other Recalls by Stryker GmbH

Class II: Risk 05/28/2025

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