BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm

    Recall: Z-1131-2026 · Reported January 28, 2026

    Enforcement

    Recall Number
    Z-1131-2026
    Event ID
    98214
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tyber Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 28, 2026
    Initiation Date
    December 19, 2025
    Classification Date
    January 20, 2026
    Address
    83 S Commerce Way Ste 310, Bethlehem, PA, 18017-8934, United States

    Description

    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm

    Reason

    The supplier manufactured anatomical left plates with an incorrect thread orientation.

    Code Info

    Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;

    Distribution

    US Nationwide distribution in the state of PA.

    Quantity

    100 units