Stryker GmbH Recall: Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935
Stryker GmbH Recall: Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Stryker GmbH; Product: Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indi
| Recalling firm | Stryker GmbH |
|---|---|
| Product | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. 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 Corre |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA. |
| Recall initiated | 20180828 |
| Recall number | Z-0291-2019 |
| Category | device |
| State | N/A |
| Country | Switzerland |
$29/mo
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