stryker Hoffmann LRF — Class II medical device recall Z-1191-2023
Ongoing recall by Stryker GmbH, reported 2023-03-08, distributed nationwide. Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically,
| Recall number | Z-1191-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, N/A, Switzerland |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-01 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 488 units |
| 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 and 1 more |
| Model numbers | 4933-0-400 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1191-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.