BEUDAMED
    FDA Recall Terminated

    CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.

    Recall: Z-0828-2011 · Initiated November 10, 2010

    Recall

    Recall Number
    Z-0828-2011
    Event Number
    57286
    FEI Number
    1000116912
    Product Code
    HWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2010
    Posted
    December 28, 2010
    Terminated
    April 25, 2011
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.

    Reason

    Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.

    Action

    DJO issued an Urgent Recall Notice letter dated November 10, 2010 to consignees identifying the affected devices and requesting return of all affected devices for replacement. Customers are also requested to complete and return an enclosed Recall Response Form. Customers can contact David Harris of DJO at 512 834-6330 with questions about this recall.

    Distribution

    Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.

    Quantity

    27 Units