BEUDAMED
    FDA Enforcement Class II Completed

    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

    Recall: Z-1236-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1236-2022
    Event ID
    90133
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    New Standard Device Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    June 8, 2020
    Classification Date
    June 3, 2022
    Address
    4848 Research Dr, San Antonio, TX, 78240-5005, United States

    Description

    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

    Reason

    1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.

    Code Info

    UDI: 854641008419, Lots: A29518X and A17219DA

    Distribution

    US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.

    Quantity

    426