BEUDAMED
    FDA Recall Terminated

    ROSA Surgical Device 2.5.8

    Recall: Z-0115-2018 · Initiated April 8, 2016

    Recall

    Recall Number
    Z-0115-2018
    Event Number
    77743
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 8, 2016
    Terminated
    July 13, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    ROSA Surgical Device 2.5.8

    Reason

    Potential for software to change the final tool orientation for the command position without command.

    Action

    Field Service Technicians visited consignee locations to perform system upgrades and have been completed.

    Distribution

    AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom

    Quantity

    64 units