Reported Mar 8, 2023 · Ongoing
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep…
Stryker GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker GmbH · Bohnackerweg 1 · Selzach, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Serial numbers
D32158D32160D32161D32162D32163D32164D34343D34344D40690D41629D41630D41631D44713G16331G16332G16333G26278G29759G29760G32730G32731G32735G45119H30398H30399H66392
- Serial numbers
- Amount recalled
- 488 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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