BEUDAMED
    FDA Enforcement Class III Terminated

    Doyen-Collin Mouth Gag 120MM/ General Instruments

    Recall: Z-1358-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1358-2018
    Event ID
    79656
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    February 16, 2018
    Classification Date
    April 11, 2018
    Termination Date
    June 30, 2020
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Doyen-Collin Mouth Gag 120MM/ General Instruments

    Reason

    The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

    Code Info

    OM040R

    Distribution

    nationwide