Stryker recalls specific models of Hoffmann LRF Bone Transport Struts due to oversized thread pitch causing improper locking. Affected units have serial numbers listed in the recall notice.
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.
Stryker is recalling specific models of orthopedic external fixation devices (Hoffmann LRF Bone Transport Struts) because the threaded rod has an oversized thread pitch at the distal end. This prevents the distal ring from locking securely between 0-50mm of the threaded rod, potentially leading to improper bone fixation.
The thread pitch is oversized at the distal end of the threaded rod, which means the distal ring fixation cannot be locked securely between 0-50mm of the threaded rod. This could result in the device not holding bone fragments properly, potentially causing movement or displacement of the bone segments.
Orthopedic patients using the specific model of Hoffmann LRF Bone Transport Struts with the listed serial numbers are affected. Patients with active bone fractures requiring external fixation are most at risk.
Check if your device has the model number 4933-0-400 and the listed serial numbers: D32158, D32160, D32161, D32162, D32163, D32164, D34343, D34344, D40690, D41629, D41630, D41631, D44713, G16331, G16332, G16333, G26278, G29759, G29760, G32730, G32731, G32735, G45119, H30398, H30399, H66392.
Compare your device's serial number to the list provided in the recall notice to determine if it is affected.
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts where the thread pitch is oversized at the distal end, preventing the distal ring from locking securely between 0-50mm of the threaded rod.
The recall notice does not specify a remedy for affected devices. Check the list of serial numbers to confirm if your device is affected.
The oversized thread pitch could prevent proper locking of the distal ring, potentially leading to improper bone fixation. However, the recall indicates this is a nonconformance issue rather than an immediate safety hazard.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1191-2023 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1191-2023 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
