A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation...
FDA Device Recall #Z-1224-2025 — Class II — January 21, 2025
Recall Summary
| Recall Number | Z-1224-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 21, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tyber Medical |
| Location | Bethlehem, PA |
| Product Type | Devices |
| Quantity | 208 units |
Product Description
A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
Reason for Recall
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Distribution Pattern
Nationwide
Lot / Code Information
UDI-DI 00196449016020; Lot Numbers 265817, 24060DF08, 263511, 24057DF02, 24057DF04
Other Recalls from Tyber Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1131-2026 | Class II | Brand Name: VOLT" Wrist Treatment System Produ... | Dec 19, 2025 |
| Z-1132-2026 | Class II | Brand Name: VOLT" Wrist Treatment System Produ... | Dec 19, 2025 |
| Z-1217-2025 | Class II | A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- ... | Jan 21, 2025 |
| Z-1219-2025 | Class II | A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Ti... | Jan 21, 2025 |
| Z-1222-2025 | Class II | A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial T... | Jan 21, 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.