BEUDAMED
    FDA Enforcement Class II Terminated

    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

    Recall: Z-1138-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1138-2013
    Event ID
    64486
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bacterin International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 24, 2013
    Initiation Date
    February 21, 2013
    Classification Date
    April 17, 2013
    Termination Date
    July 1, 2013
    Address
    600 Cruiser Ln, N/A, Belgrade, MT, 59714-9719, United States

    Description

    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

    Reason

    The firm's retesting procedure was not validated.

    Code Info

    B100164 and B110115

    Distribution

    USA Nationwide Distribution

    Quantity

    165