BEUDAMED
    FDA Recall Terminated

    InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, Interpore Cross International, a Biomet company (lnterGro DBM products contain human tissue (allograft bone) and are intended for transplantation)

    Recall: Z-0618-2008 · Initiated October 15, 2007

    Recall

    Recall Number
    Z-0618-2008
    Event Number
    45469
    Firm
    Interpore Cross International Inc
    FEI Number
    1000160576
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 15, 2007
    Posted
    February 14, 2008
    Terminated
    September 25, 2008
    Address
    181 Technology Dr, Irvine, CA, 92618-2402

    Description

    InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, Interpore Cross International, a Biomet company (lnterGro DBM products contain human tissue (allograft bone) and are intended for transplantation)

    Reason

    Unapproved Testing:Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human

    Action

    The Recall Notification letters will be sent via commercial carrier (UPS) with signature for verification of receipt required on Friday October 26, 2007, to all consignees, including hospitals and sales representatives, which summarizes the recall details and instructs the consignee to contact Interpore Cross via mail or facsimile with the enclosed Customer Response form, and to immediately return the affected product.

    Distribution

    Nationwide

    Quantity

    1,256