BEUDAMED
    FDA Recall Terminated

    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components

    Recall: Z-1881-2017 · Initiated October 6, 2011

    Recall

    Recall Number
    Z-1881-2017
    Event Number
    75614
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    FEI Number
    3003714383
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 6, 2011
    Posted
    April 26, 2017
    Terminated
    May 8, 2017
    Address
    75 Queen St, Montreal Canada # 3300

    Description

    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components

    Reason

    Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.

    Action

    Zimmer sent a Medical Device Field Notification letter dated December 6, 2011, to all affected customers. This is a retrospective report of a correction taken on 6 December 2011. The software issues were fixed in the new software version 2.3.3.0. Recall notices were distributed on December 6, 2011. Telephone: 18663367846 (US & Canada) or 5143958883 (International), Email: [email protected] Customers with questions should call 1-866-336-7846 (US & Canada) 514-395-8883 (International). For questions regarding this recall call 574-372-4487.

    Distribution

    Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand

    Quantity

    105