FDA-Device2023-03-08Class II
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
Stryker GmbH
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.
Sold states
US Nationwide distribution.
Affected count
488 units
Manufactured in
Bohnackerweg 1, N/A, Selzach, N/A, Switzerland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1191-2023Don't want to check this manually?
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