Z-1224-2025 Class II Ongoing

Recalled by Tyber Medical — Bethlehem, PA

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