FDA Device recall Z-0289-2019
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020
- FDA Device
- Class II
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class II recall of Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020 by Stryker, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0289-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-28 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker |
| Distribution | US |
Product
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. 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 foot reconstruction Lisfranc dislocations The typical LRF construct features two or more rings bridged by three to four telescopic struts with multiplanar, ball jointed fixation bolts. Once applied, the LRF can be unlocked for gross frame adjustment and fracture reduction. The LRF can be finely adjusted to aid in limb alignment and definitively locked to hold compression and reduction. If deemed appropriate, the LRF Telescopic Struts can provide up to 5mm of controlled dynamization. Original Statement OP-Tech H-ST-1_Rev2_HoffmannLRF_OpTech_2016-10690]
Reason
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.
Identifiers
| code_info | Lots: L18237 L13688 L22248 L25187 L31271 L35846 L46782 L47078 L47196 L50180 L51361 L53108 L53489 L57504…Lots: L18237 L13688 L22248 L25187 L31271 L35846 L46782 L47078 L47196 L50180 L51361 L53108 L53489 L57504 L58108 L57506 Y00082 Y02871 Y03127 Y08559 Y08560 Y12875 Y14371 Y14640 Y14644 Y14645 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2019%22
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