BEUDAMED
    FDA Enforcement Class II Terminated

    MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.

    Recall: Z-1755-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1755-2017
    Event ID
    76820
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    February 27, 2017
    Classification Date
    April 7, 2017
    Termination Date
    August 6, 2019
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.

    Reason

    Unapproved change made by the supplier.

    Code Info

    Serial #'s: SP16008

    Distribution

    Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.

    Quantity

    1