BEUDAMED
    FDA Recall 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 · Initiated February 28, 2017

    Recall

    Recall Number
    Z-1512-2017
    Event Number
    76603
    Firm
    Devicor Medical Products Inc
    FEI Number
    3008492462
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 28, 2017
    Posted
    March 8, 2017
    Terminated
    August 3, 2017
    Address
    300 E Business Way, Fl 5, Cincinnati, OH, 45241-2384

    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.

    Action

    Devicor sent an Urgent Medical Device Recall letter dated March 10, 2017 to all affected consignees via first class mail. The recall response rate will be tracked and reconciled by consignee's response form, certifications of product inventory, and/or disposal. Consignees were asked to complete and return the enclosed response form as soon as possible. Consignees with any questions were instructed to call Mammotome Customer Service at 1-877-926-2666. For questions regarding this recall call 513-864-9158.

    Distribution

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

    Quantity

    320