Events

Recall of Device Recall OsteoSelect

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
    64486
  • Event Risk Class
    Class 2
  • Event Number
    Z-1138-2013
  • Event Initiated Date
    2013-02-21
  • Event Date Posted
    2013-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116258
  • 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, calcium compound - Product Code MBP
  • Reason
    The firm's retesting procedure was not validated.
  • 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.

Device

Device Recall OsteoSelect
  • Model / Serial
    B100164 and B110115
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution
  • Product Description
    OsteoSelect DBM Putty || Product Usage: || Orthopedic bone filler
  • 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