Z-1138-2013Class II

OsteoSelect DBM Putty

Name: Z-1138-2013 OsteoSelect DBM Putty
Creator: Bacterin International, Inc.
Published: 2013-02-21
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2013-02-21 / Terminated / root cause: manufacturing process

FDA source

Bacterin International, Inc. began a recall of OsteoSelect DBM Putty Product Usage: Orthopedic bone filler on 2013-02-21. FDA classified it as Class II and gives the reason as "The firm's retesting procedure was not validated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1138-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-21
Posted: 2013-04-17
Terminated: 2013-07-01
Recalling firm: Xtant Medical Holdings, Inc.
Product: OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Reason for recall: The firm's retesting procedure was not validated.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 165
Distribution: USA Nationwide Distribution
Product codes and lots: B100164 and B110115

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1138-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1138-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

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)