BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1692-2013 · Initiated May 30, 2013

    Recall

    Recall Number
    Z-1692-2013
    Event Number
    65554
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 30, 2013
    Posted
    July 11, 2013
    Terminated
    July 12, 2013
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    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.

    Action

    DeRoyal sent an Urgent: Voluntary Product Recall letter dated May 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, remove any affected product from their inventory, open its package to prevent use, and dispose in a standard trash receptacle. Customers were asked to complete the enclosed notice of destruction form and return it to DeRoyal by faxing it to 865-362-3716 or emailing it to [email protected]. For question call 865-362-1034 or contact your DeRoyal representative.

    Distribution

    USA Nationwide Distribution in the state of PA

    Quantity

    87 units