BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1280-2022 · Initiated August 14, 2019

    Recall

    Recall Number
    Z-1280-2022
    Event Number
    90159
    Firm
    New Standard Device Inc
    FEI Number
    3015536247
    Product Code
    HXC
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 14, 2019
    Address
    4848 Research Dr, San Antonio, TX, 78240-5005

    Description

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

    Reason

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

    Action

    On 08/19/2019, the firm sent via email an "FIELD SAFETY NOTICE" informing customers that the Slotted 90 degree Tubular Wrench was stripping when torqueing nuts in the application process. Customers were asked to: -remove the affected products from inventory and return to Metalogix Inc. at 4848 Research Drive, San Antonio, TX 78240 ATTENTION: QA Dept.

    Distribution

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

    Quantity

    14 devices