BEUDAMED
    FDA Recall Terminated

    DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

    Recall: Z-1455-2015 · Initiated December 4, 2014

    Recall

    Recall Number
    Z-1455-2015
    Event Number
    70739
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    FEI Number
    3001236616
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 4, 2014
    Posted
    April 17, 2015
    Terminated
    May 8, 2017
    Address
    125 May St, Ste 300, Edison, NJ, 08837-3264

    Description

    DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.

    Reason

    The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.

    Action

    MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.

    Distribution

    US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.

    Quantity

    25 units