Z-1224-2025 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
- 208 units
Product Description
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
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 00196449016020; Lot Numbers 265817, 24060DF08, 263511, 24057DF02, 24057DF04