BEUDAMED
    FDA Recall Terminated

    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument

    Recall: Z-2075-2017 · Initiated June 20, 2008

    Recall

    Recall Number
    Z-2075-2017
    Event Number
    75612
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    FEI Number
    3003714383
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 20, 2008
    Posted
    May 12, 2017
    Terminated
    May 15, 2017
    Address
    75 Queen St, Montreal Canada # 3300

    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.

    Action

    This is a retrospective report of a correction taken on 20 June 2008. The two software issues were corrected in the new software version 2.2.1.3. There were 164 copies of the affected software, 5 of which were only temporary licenses. There were 152 of the 159 software copies that had a full license that were confirmed to have installed the updated instructions per the correction notice for a total percentage of 96%. All sales representatives were made aware of the software issues by written notice. Both software issues were corrected in a new revision of the software with no remaining effect. There have been no complaints since the correction was implemented. Recall notices were e-mailed to customers dated 06/20/2008.

    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