BEUDAMED
    FDA Enforcement Class II Terminated

    Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

    Recall: Z-0721-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0721-2020
    Event ID
    84328
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mazor Robotics Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    July 2, 2019
    Classification Date
    December 20, 2019
    Termination Date
    February 2, 2022
    Address
    North Industrial Park, 5, Shacham Street, Caesarea, N/A, Israel

    Description

    Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

    Reason

    The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological deficit/dysfunction

    Code Info

    Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496

    Distribution

    US: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New York, North Carolina, North Dakota, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia

    Quantity

    93 snapshot trackers