BEUDAMED
    FDA Enforcement Class II Ongoing

    A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061

    Recall: Z-1211-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1211-2025
    Event ID
    96212
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tyber Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 5, 2025
    Initiation Date
    January 21, 2025
    Classification Date
    February 21, 2025
    Address
    83 S Commerce Way Ste 310, N/A, Bethlehem, PA, 18017-8934, United States

    Description

    A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061

    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 Info

    UDI-DI 00196449015542; Lot Numbers 267846, 265782, 24043BU04, 261288

    Distribution

    Nationwide

    Quantity

    418 units