Device product
A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia
Z-1220-2025
Product summary
- Firm
- Tyber Medical
- Event
- Event 96212
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 210 units
- Official record key
device-enforcement:Z-1220-2025
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 00196449015986; Lot Numbers 265792, 24053DF01, 24065DF06, 24052DF01
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