BEUDAMED
    FDA Recall Terminated

    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    Recall: Z-0800-2013 · Initiated April 18, 2012

    Recall

    Recall Number
    Z-0800-2013
    Event Number
    63433
    Firm
    Bacterin International, Inc.
    FEI Number
    3005031160
    Product Code
    MBP
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    April 18, 2012
    Posted
    February 11, 2013
    Terminated
    May 13, 2013
    Address
    600 Cruiser Ln, Belgrade, MT, 59714-9719

    Description

    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    Reason

    Expired product was shipped to two customers.

    Action

    Bacterin International phoned the two customers and they were instructed to return any of the unused product. For questions regarding this recall call 406-388-0480. The 3rd expired product was discovered by Bacterin Sales Rep 7/12/2012 at the consignee.

    Distribution

    Nationwide Distribution in TX , GA and CA.

    Quantity

    3 packages each containing 2.5cc of putty