Stryker GmbH: Device Recall

Recall #Z-2219-2024 · 05/09/2024

Class II: Risk

Recall Details

Recall Number: Z-2219-2024
Classification: Class II
Product Type: Device
Recalling Firm: Stryker GmbH
Status: Ongoing
Date Initiated: 05/09/2024
Location: Selzach, Switzerland
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 39 devices

Reason for Recall

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

Product Description

Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.

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 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.

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.