Z-1217-2025 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
100 units

Product Description

A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121

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 00196449015603; Lot Numbers 262560, 260893