BEUDAMED
    FDA Recall Terminated

    Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

    Recall: Z-0609-2019 · Initiated November 26, 2014

    Recall

    Recall Number
    Z-0609-2019
    Event Number
    81521
    Firm
    Mazor Robotics Ltd
    FEI Number
    3005075696
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 26, 2014
    Terminated
    July 3, 2019
    Address
    5 Shacham Street P.O. Box 3104, North Industrial Park Israel

    Description

    Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

    Reason

    In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.

    Action

    All Mazor Brain Clinical Sales Representatives (support during clinical cases) were notified of the issue on 11/26/2014 via email as well as received training.

    Distribution

    Affected devices were distributed in the US to four different medical facilities in four states

    Quantity

    5 units