BEUDAMED
    FDA Recall Terminated

    DS Titanium Ligation Clip Appliers, used in laparoscopic surgery

    Recall: Z-1291-2018 · Initiated January 22, 2018

    Recall

    Recall Number
    Z-1291-2018
    Event Number
    79530
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 22, 2018
    Terminated
    September 24, 2019
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    DS Titanium Ligation Clip Appliers, used in laparoscopic surgery

    Reason

    Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.

    Action

    A letter and copy of the updated IFU was sent to affected customers the week of January 15, 2018. Product does not need to be returned. IFU is revised and put on the Aesculap Website for usage. https://www.aesculapusa.com/products/instructions-for-use.

    Distribution

    US and Canada distribution

    Quantity

    270