BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1236-2022 · Initiated June 8, 2020

    Recall

    Recall Number
    Z-1236-2022
    Event Number
    90133
    Firm
    New Standard Device Inc
    FEI Number
    3015536247
    Product Code
    KTT
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    June 8, 2020
    Address
    4848 Research Dr, San Antonio, TX, 78240-5005

    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.

    Action

    On 06/08/2020, Market Withdrawal notices were emailed to customers who were asked to remove affected truss wires from inventory and return to the recalling firm. Customers were informed to use alternate 1.8mm and 2.0mm unaffected smooth wires. Upon completion of verification testing, both 2.0mm truss and smooth wires will be released for use. Customers with additional questions are encouraged to call (833) 659-2019 Ext 6.

    Distribution

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

    Quantity

    426