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FDAFDA · Food and drugs·Recall number Z-2219-2024

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

Published July 3, 2024 · Recall initiated: May 9, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Stryker GmbH
Distributor
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.
Lot
Lot #J43995, UDI-DI 07613252611035.
Risk classification
Class II
Area (FDA)
device
Country
Switzerland

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