BEUDAMED
    FDA Recall Terminated

    ROSA Surgical Device 2.5.8 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-0161-2018 · Initiated June 4, 2014

    Recall

    Recall Number
    Z-0161-2018
    Event Number
    77750
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    June 4, 2014
    Terminated
    June 16, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    ROSA Surgical Device 2.5.8 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

    Software corrections reactivating the cooperative endoscopy mode.

    Action

    The firm, Zimmer Biomet Inc., sent Field Service Technicians to consignee locations to perform system upgrade. All US units have been corrected. If you any question, please contact Post Market Surveillance and Regulatory Compliance Director at 574-372-4487 or email to: [email protected].

    Distribution

    Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.

    Quantity

    29 devices(8 US and 21 OUS)