BEUDAMED
    FDA Recall Terminated

    Navitrack System - OS Knee Universal, Stereotaxic instrument

    Recall: Z-2076-2017 · Initiated October 28, 2008

    Recall

    Recall Number
    Z-2076-2017
    Event Number
    75613
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    FEI Number
    3003714383
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 28, 2008
    Posted
    May 12, 2017
    Terminated
    May 15, 2017
    Address
    75 Queen St, Montreal Canada # 3300

    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 .

    Action

    This is a retrospective report of a correction taken on 28 October, 2008. The software issues mentioned above were corrected in subsequent software updates. There were 153 units of the affected software distributed. There were 147 of the 153 units confirmed to have installed the updated software per the correction notice for a total percentage of 96%. Recall Notices were sent to customers on 10/28/2008.

    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