BEUDAMED
    FDA Enforcement Class II Ongoing

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    Recall: Z-1280-2022 · Reported June 29, 2022

    Enforcement

    Recall Number
    Z-1280-2022
    Event ID
    90159
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    New Standard Device Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2022
    Initiation Date
    August 14, 2019
    Classification Date
    June 21, 2022
    Address
    4848 Research Dr, San Antonio, TX, 78240-5005, United States

    Description

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    Reason

    Due to manufacturing processing error, wrench causing stripping when torqueing nuts.

    Code Info

    Catalog/Part Number: 900104 UDI-DI (GTIN): 854641008112 Lot Number: A29618A

    Distribution

    U.S.: AZ. CT, GA, OH, and VA O.U.S.: N/A

    Quantity

    14 devices