BEUDAMED
    FDA Enforcement Class II Terminated

    Navitrack System - OS Knee Universal, Stereotaxic instrument

    Recall: Z-2076-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2076-2017
    Event ID
    75613
    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 24, 2017
    Initiation Date
    October 28, 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, Stereotaxic instrument

    Reason

    Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .

    Code Info

    Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42

    Distribution

    Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Zealand Spain Sweden Switzerland United Kingdom

    Quantity

    153