Stryker GmbH is recalling 39 units of the Stryker Hoffman LRF Wire Tensioner, model REF 4933-9-100, which is a component of the Hoffmann LRF surgical system. The adjustment ring on these devices may become loose, which prevents the wire tension from being set correctly during surgical procedures. Consumers should be aware that this defect could impact the stability or precision of the surgical fixator system. These devices were distributed worldwide, including 13 U.S. states, and were identified by specific lot numbers and UDI codes.
A loose adjustment ring prevents the device from maintaining the correct wire tension, which could lead to improper stabilization of bone fragments or surgical hardware during a procedure.
Manufacturer Notification and Device Return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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