BEUDAMED
    FDA Recall Terminated

    RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

    Recall: Z-1405-2022 · Initiated June 30, 2021

    Recall

    Recall Number
    Z-1405-2022
    Event Number
    90537
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HXW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2021
    Terminated
    April 17, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

    Reason

    Customized coronal rod benders may deform the implant when used with the spinal system devices.

    Action

    A recall notification titled "Medical Device Market Withdrawal Notification" was emailed June 30, 2021. The letter identifies the affected product as Customized Coronal Rod Benders TEK 1939 and TEK 1940 and requests the customer to 1) Identify affected inventory, 2) Discontinue use, 3) Submit the acknowledgement form and 4) Contact AIS Customer Service to arrange for return of affected product at (866) 229-3002.

    Distribution

    United States: CO

    Quantity

    2 pieces