Device product
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
Z-1210-2025
Product summary
- Firm
- Tyber Medical
- Event
- Event 96212
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 397
- Official record key
device-enforcement:Z-1210-2025
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 00196449015535; Lot Numbers 267845, 261287, 265780, 24033BU01
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