Z-0800-2013Class II

Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor#...

Name: Z-0800-2013 Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor#...
Creator: Bacterin International, Inc.
Published: 2012-04-18
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2012-04-18 / Terminated

FDA source

Bacterin International, Inc. began a recall of Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL... on 2012-04-18. FDA classified it as Class II and gives the reason as "Expired product was shipped to two customers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0800-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-18
Posted: 2013-02-11
Terminated: 2013-05-13
Recalling firm: Xtant Medical Holdings, Inc.
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
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Reason for recall: Expired product was shipped to two customers.
FDA root cause: Incorrect or no expiration date
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.
Quantity in commerce: 3 packages each containing 2.5cc of putty
Distribution: Nationwide Distribution in TX , GA and CA.
Product codes and lots: Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011. A thrid graft with ID# B100078-908 expiration date 04/27/2012 was added to the recall 7/12/2012.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0800-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0800-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-11

Product code MBP

K091321Class IIOsteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. / cleared 2009-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)