BEUDAMED
    FDA Recall Terminated

    AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine

    Recall: Z-1298-2008 · Initiated October 17, 2007

    Recall

    Recall Number
    Z-1298-2008
    Event Number
    46780
    Firm
    LifeCell Corporation
    FEI Number
    1000306051
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    October 17, 2007
    Posted
    March 26, 2008
    Terminated
    May 14, 2008
    Address
    1 Millennium Way, Somerville, NJ, 08876-3876

    Description

    AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine

    Reason

    Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)

    Action

    Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.

    Distribution

    All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.

    Quantity

    46 kits