BEUDAMED
    FDA Recall Terminated

    DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

    Recall: Z-1071-2010 · Initiated December 9, 2009

    Recall

    Recall Number
    Z-1071-2010
    Event Number
    54113
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 9, 2009
    Posted
    March 11, 2010
    Terminated
    May 20, 2010
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

    Reason

    Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility

    Action

    DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009

    Distribution

    LA & MS

    Quantity

    194 units