Events

Recall of Osteoselect Demineralized Bone Matrix DMB Putty

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bacterin International, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63433
  • Event Risk Class
    Class 2
  • Event Number
    Z-0800-2013
  • Event Initiated Date
    2012-04-18
  • Event Date Posted
    2013-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113766
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
  • 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.

Device

Osteoselect Demineralized Bone Matrix DMB Putty
  • Model / Serial
    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.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution in TX , GA and CA.
  • 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
  • Manufacturer
    Bacterin International, Inc.

Manufacturer

Bacterin International, Inc.
  • Manufacturer Address
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • Manufacturer Parent Company (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA