BEUDAMED
    FDA Recall Terminated

    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

    Recall: Z-1383-2022 · Initiated September 25, 2019

    Recall

    Recall Number
    Z-1383-2022
    Event Number
    90483
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HXK
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 25, 2019
    Terminated
    April 1, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

    Reason

    Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

    Action

    Field Action Notification letter was issued September 25, 2019 via letter sent USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or via email at: [email protected]

    Distribution

    United States: TX and AK

    Quantity

    7 pieces