BEUDAMED
    FDA Enforcement Class III Terminated

    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

    Recall: Z-2075-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2075-2017
    Event ID
    75612
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 24, 2017
    Initiation Date
    June 20, 2008
    Classification Date
    May 12, 2017
    Termination Date
    May 15, 2017
    Address
    75 Queen St #3300, Montreal, N/A, Canada

    Description

    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

    Reason

    ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

    Code Info

    Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82

    Distribution

    Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom

    Quantity

    152