BEUDAMED
    FDA Enforcement Class II 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 · Reported January 11, 2017

    Enforcement

    Recall Number
    Z-0947-2017
    Event ID
    75937
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2017
    Initiation Date
    October 28, 2016
    Classification Date
    January 5, 2017
    Termination Date
    January 30, 2018
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    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.

    Code Info

    Material Code MG096R  (1.1 CM) MG097R  (1.3 CM) MG227 (1.45CM) MG228  (1.6CM) MG229  (2.1 CM) MG230  (2.6CM)

    Distribution

    Nationwide Distribution

    Quantity

    437 units