Device product
A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101
Z-1221-2025
Product summary
- Firm
- Tyber Medical
- Event
- Event 96212
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 200 units
- Official record key
device-enforcement:Z-1221-2025
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 00196449015993; Lot numbers 265814, 24060DF02, 24065DF03, 24060DF01. 24065DF05, 263512
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