Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The ...
FDA Device Recall #Z-0290-2019 — Class II — August 28, 2018
Recall Summary
| Recall Number | Z-0290-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 28, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker GmbH |
| Location | Selzach, N/A |
| Product Type | Devices |
| Quantity | 1355 |
Product Description
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.
Distribution Pattern
US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.
Lot / Code Information
Lots: L18238 L13689 L22249 L26333 L31075 L31035 L35849 L35850 L45970 L46580 L47080 L46577 L46781 L47195 L49918 L49816 L51362 L53106 L53487 L53823 L53488 L56830 L56831 L57502 Y00081 Y00080 Y02872 Y02873 Y03128 Y07628 Y07630 Y08561 Y08555 Y08554 Y08553 Y12876 Y14867 Y14641
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|---|---|---|---|
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| Z-1940-2025 | Class II | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Nu... | May 22, 2025 |
| Z-1939-2025 | Class II | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Num... | May 22, 2025 |
| Z-1620-2025 | Class II | Guide Wire with Ruler Tube 3x800 mm DIA; Catalo... | Mar 28, 2025 |
| Z-1621-2025 | Class II | Guide Wire with Ruler Tube 3x1000 mm DIA; Catal... | Mar 28, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.