BEUDAMED
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    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

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·February 20, 2013

    OSTEOSELECT DBM PUTTY

    FDA Adverse Event
    Other ·BACTERIN INTERNATIONAL, INC.·Product code MQV·April 3, 2014

    ELUTIA WOUND DRAIN

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL INC.·Product code OEI·May 15, 2014

    OSTEOSELECT DBM PUTTY

    FDA Adverse Event
    Other ·BACTERIN INTERNATIONAL, INC.·Product code MQV·April 3, 2014

    ELUTIA

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL INC.·Product code OEI·February 26, 2013

    OSTEOSELECT DBM PUTTY

    FDA Adverse Event
    Other ·BACTERIN INTERNATIONAL INC.·Product code MQV·February 19, 2013

    OSTEOSELECT DBM PUTTY

    FDA Adverse Event
    Other ·BACTERIN INTERNATIONAL, INC.·Product code MQV·March 15, 2013

    OSTEOSELECT DBM PUTTY

    FDA Adverse Event
    Other ·BACTERIN INTERNATIONAL INC.·Product code MQV·February 19, 2013

    OSTEOSELECT DBM PUTTY

    FDA Adverse Event
    Other ·BACTERIN INTERNATIONAL, INC.·Product code MQV·March 15, 2013

    OSTEOSELECT DBM PUTTY IN A SYRINGE 5.0CC

    FDA Adverse Event
    Other ·BACTERIN INTERNATIONAL INC.·Product code MQV·February 19, 2014

    OSTEOSELECT

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL, INC.·Product code MBP·March 21, 2017

    OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL, INC.·Product code MBP·May 8, 2019

    OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL, INC.·Product code MBP·May 8, 2019

    OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL, INC.·Product code MBP·May 8, 2019

    OSTEOWRAP

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL, INC.·Product code MBP·April 3, 2023

    OSTEO-LOCK

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL, INC.·Product code LXH·September 20, 2018

    DBM PUTTY 5.0CC, AXOGRAFT

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL, INC.·Product code MBP·September 14, 2017

    NA

    FDA Adverse Event
    Malfunction ·BACTERIN INTERNATIONAL INC.·Product code LXH·April 14, 2015

    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

    FDA Recall
    Terminated ·Bacterin International, Inc.·Product code MBP·April 18, 2012

    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.

    FDA Recall
    Terminated ·Bacterin International, Inc.·Product code LXH·March 9, 2015