# FDA recall Z-1191-2023

> **Stryker GmbH** · Class II · device recall initiated 2023-02-07.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1191-2023
- **Recalling firm:** Stryker GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-07
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Selzach, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1191-2023

## Citation

> AI Analytics. FDA recall Z-1191-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1191-2023. Source: US FDA. Licensed CC0.

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