BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1455-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1455-2015
    Event ID
    70739
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Musculoskeletal Transplant Foundation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 29, 2015
    Initiation Date
    December 4, 2014
    Classification Date
    April 17, 2015
    Termination Date
    May 8, 2017
    Address
    125 May St Ste 300, Edison, NJ, 08837-3264, United States

    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.

    Code Info

    064130067910690008; 064130067910690009; 064130067910690004; 064130067910690023; 064130067910690024 064130067910690005; 064130067910690015; 064130067910690016; 064130067910690018; 064130067910690020; 064130067910690007; 064130067910690013; 064130067910690028; 064130067910690029; 064130067910690030; 064130067910690010; 064130067910690006; 064130067910690011; 064130067910690012; 064130067910690019; 064130067910690021; 064130067910690014; 064130067910690017; 064130067910690001; 064130067910690022

    Distribution

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

    Quantity

    25 units