BEUDAMED
    FDA Enforcement Class II Terminated

    Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance

    Recall: Z-1512-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1512-2017
    Event ID
    76603
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Devicor Medical Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    February 28, 2017
    Classification Date
    March 21, 2017
    Termination Date
    August 3, 2017
    Address
    300 E Business Way Fl 5, Cincinnati, OH, 45241-2384, United States

    Description

    Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance

    Reason

    The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.

    Code Info

    F11621304D1

    Distribution

    Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil

    Quantity

    320