BEUDAMED
    FDA Enforcement Class II Terminated

    GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

    Recall: Z-1692-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1692-2013
    Event ID
    65554
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 17, 2013
    Initiation Date
    May 30, 2013
    Classification Date
    July 11, 2013
    Termination Date
    July 12, 2013
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

    Reason

    DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.

    Code Info

    Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366

    Distribution

    USA Nationwide Distribution in the state of PA

    Quantity

    87 units