Recall Z-0800-2013— Bacterin International, Inc.

Name: FDA recall Z-0800-2013
Creator: U.S. Food and Drug Administration
Published: 2012-04-18

Class II · Terminated

Class II FDA medical device recall by Bacterin International, Inc., initiated 2012-04-18, terminated 2013-05-13. It names one FDA 510(k) clearance: K091321. Product: 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..

Recalling firm: Bacterin International, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-04-18
Terminated: 2013-05-13
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K091321 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.·cleared 2009-09-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

Expired product was shipped to two customers.

Data sourced from openFDA. This site is unofficial and independent of the FDA.