Home / Recalls / Medical Devices
Stryker GmbH recalls stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bon
Recalled March 8, 2023 · FDA recall Z-1191-2023 · Stryker
Hazard
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod. · FDA Class II
Units
488 units
Sold at
US Nationwide distribution.
Description
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
Product
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
Manufacturer(s)
Stryker GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →