FDA Device recall Z-1191-2023
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400 by Stryker, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1191-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-07 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | Serial numbers: D32158, D32160, D32161, D32162, D32163, D32164, D34343, D34344, D40690, D41629, D41630, D41631, D44713…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1191-2023%22
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