BEUDAMED
    FDA Recall Terminated

    NDI P7 Position Sensor, Stereotaxic Instrument

    Recall: Z-2048-2017 · Initiated June 9, 2009

    Recall

    Recall Number
    Z-2048-2017
    Event Number
    75615
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    FEI Number
    3003714383
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 9, 2009
    Posted
    May 8, 2017
    Terminated
    May 9, 2017
    Address
    75 Queen St, Montreal Canada # 3300

    Description

    NDI P7 Position Sensor, Stereotaxic Instrument

    Reason

    Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.

    Action

    Zimmer CAS sent an Field Recall Notice dated June 9, 2009. Zimmer CAS conducted a retrospective recall/Field Correction on given P7 Position Sensors (Cameras). These were installed on given Sesamoid and Sesamoid Plasty CAS workstations. A series of these components have been determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage. The failure mode consists in the camera stopping to track and interrupting the application with an error code 0X00000020 being displayed on the navigation panel. For any questions or concerns please contact the Zimmer CAS customer service, 1-866-336-7846.

    Distribution

    Worldwide Distribution - US Distribution to the states of : KS, MS, WI, NJ, KS, IN, LA, FL and WA., and to the countries of : Canada, Australia, Singapore, Netherlands, UK, Austria, Germany, Switzerland and Czech Republic.

    Quantity

    34