BEUDAMED
    FDA Enforcement Class II Terminated

    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate

    Recall: Z-0100-2018 · Reported November 22, 2017

    Enforcement

    Recall Number
    Z-0100-2018
    Event ID
    77667
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 22, 2017
    Initiation Date
    April 19, 2012
    Classification Date
    November 16, 2017
    Termination Date
    June 16, 2020
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate

    Reason

    Potential failure of the optical distance sensor due to cable disconnection.

    Code Info

    Serial No. RO10011 and RO10014

    Distribution

    Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy

    Quantity

    14 units