BEUDAMED
    FDA Recall Terminated

    OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054

    Recall: Z-0825-2008 · Initiated October 23, 2007

    Recall

    Recall Number
    Z-0825-2008
    Event Number
    45502
    FEI Number
    2242816
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 23, 2007
    Posted
    February 14, 2008
    Terminated
    April 15, 2008
    Address
    EBI, L.P. 100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    Description

    OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054

    Reason

    Unapproved Testing: Tissue supplier (LifeLink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA approved donor screening test. (Note: tissue samples were later re-tested by an approved method and found non-reactive)

    Action

    Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.

    Distribution

    Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS

    Quantity

    19 units