Hoffman LRF Hexapod Strut — Class II medical device recall Z-0290-2019
Terminated recall by Stryker GmbH, reported 2018-11-07, distributed nationwide. The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specificatio
| Recall number | Z-0290-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, N/A, Switzerland |
| Recall initiated | 2018-08-28 |
| Classified | 2018-10-29 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2021-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,355 |
| Reason classes | specification failure |
| Lot numbers | L13689, L18238, L22249, L26333, L31035, L31075, L35849, L35850, L45970, L46577, L46580, L46781, L47080, L47195, L49816, L49918, L51362, L53106, L53487, L53488, L53823, L56830, L56831, L57502, Y00080, Y00081, Y02872, Y02873, Y03128, Y07628, Y07630, Y08553, Y08554, Y08555, Y08561, Y12876, Y14641, Y14867 |
| Model numbers | 4935-0-030 |
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 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 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.
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-0290-2019. 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.