Device product
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
Z-1224-2025
Product summary
- Firm
- Tyber Medical
- Event
- Event 96212
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 208 units
- Official record key
device-enforcement:Z-1224-2025
Official wording
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
Code information: UDI-DI 00196449016020; Lot Numbers 265817, 24060DF08, 263511, 24057DF02, 24057DF04
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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