# FDA recall Z-0290-2019

> **Stryker GmbH** · Class II · device recall initiated 2018-08-28.

## Product

Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:   Open and closed fractures   Post-traumatic joint contracture which has resulted in loss of range of motion   Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction   Pseudoarthrosis or non-union of long bones   Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction   Correction of bony or soft tissue deformity   Correction of segmental bony or soft tissue defects   Joint arthrodesis   Management of communicated intra-articular fractures of the distal radius   Bone transport The Hoffmann LRF System is indicated in adults for:   Osteotomy   Revision procedure where other treatments or devices have been unsuccessful   Bone reconstruction procedures   Fusions and replantations of the foot   Charcot f

## Reason for recall

The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.

## Distribution

US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.

## Key facts

- **Recall number:** Z-0290-2019
- **Recalling firm:** Stryker GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2018-11-07
- **Termination date:** 2021-02-04

- **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-0290-2019

## Citation

> AI Analytics. FDA recall Z-0290-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0290-2019. Source: US FDA. Licensed CC0.

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