BEUDAMED
    FDA Enforcement Class II 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 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1881-2017
    Event ID
    75614
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2017
    Initiation Date
    October 6, 2011
    Classification Date
    April 26, 2017
    Termination Date
    May 8, 2017
    Address
    75 Queen St #3300, N/A, Montreal, N/A, N/A, Canada

    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.

    Code Info

    Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6

    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