BEUDAMED
    FDA Recall Terminated

    Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits

    Recall: Z-2008-2012 · Initiated June 16, 2012

    Recall

    Recall Number
    Z-2008-2012
    Event Number
    62457
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 16, 2012
    Posted
    July 13, 2012
    Terminated
    November 9, 2012
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits

    Reason

    Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.

    Action

    DeRoyal initiated the recall on 6/16/2012 by notifying customers by overnight delivery of letters describing the problem, instructing the customer how to handle inventory on hand, and requesting the customer to destroy the product, fill out the provided notice of destruction form, and return the form to DeRoyal. For questions customers were instructed to call 865-362-1020 or 865-362-1034. For questions regarding this recall call 865-362-2334.

    Distribution

    Nationwide Distribution including SD and NE.

    Quantity

    303 units