BEUDAMED
    FDA Recall Terminated

    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

    Recall: Z-1138-2013 · Initiated February 21, 2013

    Recall

    Recall Number
    Z-1138-2013
    Event Number
    64486
    Firm
    Bacterin International, Inc.
    FEI Number
    3005031160
    Product Code
    MBP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 21, 2013
    Posted
    April 17, 2013
    Terminated
    July 1, 2013
    Address
    600 Cruiser Ln, Belgrade, MT, 59714-9719

    Description

    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

    Reason

    The firm's retesting procedure was not validated.

    Action

    Bacterin sent a Voluntary Product Recall Notification letter via e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are being asked to return any remaining product by obtaining a Return Authorization number from them. Bacterin is also asking customers to return the verification form mailed with the recall letter regardless of whether or not they had any product on hand. For questions contact Bacterin sales representative or Bacterin Customer Service.

    Distribution

    USA Nationwide Distribution

    Quantity

    165