BEUDAMED
    FDA Recall Terminated

    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries

    Recall: Z-0947-2017 · Initiated October 28, 2016

    Recall

    Recall Number
    Z-0947-2017
    Event Number
    75937
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HFX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 28, 2016
    Terminated
    January 30, 2018
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries

    Reason

    Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.

    Action

    Aesculap sent an Urgent Medical Device Recall Notification letter dated October 28, 2016, to all affected customers were sent an Urgent Medical Device Recall Notification letter via Fed-Ex overnight.. Customers were asked to immediately remove the affect product from their inventory and return to Aesculap. A return label was provided to efficiently remove and return the affected products. Customers with questions should call 610-984-9414. For questions regarding this recall call 800-258-1946.

    Distribution

    Nationwide Distribution

    Quantity

    437 units