BEUDAMED
    FDA Recall 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-0096-2018 · Initiated December 18, 2013

    Recall

    Recall Number
    Z-0096-2018
    Event Number
    77598
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 18, 2013
    Terminated
    June 29, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    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

    Possible break in the connector of the Force Sensor.

    Action

    Customers were informed onsite by Field Service Technicians of the planned correction.

    Distribution

    Nationwide Distribution to OH, MI, and TX

    Quantity

    21 units total