Tyber Medical Recall 96212
Description: A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061
Tyber Medical Recall 96212 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1219-2025 |
| Event ID | 96212 |
| Event Description | A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 197 units |
| Recall Reason | 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 |
| Device Classification | 20250305 |
| Device Code Info | UDI-DI 00196449015979; Lot Numbers 265790, 263514, 24055DF05, 24056DF01 |
| Center Classification Date | 20250221 |
| Recall Initiation Date | 20250121 |
| Recalling Firm | Tyber Medical |
| Initial Notification | |
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