Z-1209-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2025
- Initiation Date
- January 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 412 units
Product Description
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041
Reason for Recall
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
Distribution Pattern
Nationwide
Code Information
UDI-DI; 00196449015528 Lot Numbers 24043BU03, 267844, 24043BU02, 261286