BEUDAMED
    FDA Recall Terminated

    Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

    Recall: Z-0672-2018 · Initiated October 23, 2017

    Recall

    Recall Number
    Z-0672-2018
    Event Number
    79246
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 23, 2017
    Terminated
    July 18, 2019
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803

    Description

    Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

    Reason

    There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.

    Action

    Ethicon Johnson & Johnson Affiliates in Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter identified the affected product, problems and actions to be taken.

    Distribution

    China

    Quantity

    148.913