Events

Recall of Grafton DBM Flex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Osteotech 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
    60263
  • Event Risk Class
    Class 2
  • Event Number
    Z-0415-2012
  • Event Initiated Date
    2011-08-08
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104903
  • 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
    Aseptic conditions during the production of these products may have been compromised.
  • Action
    Osteotech sent a recall letter dated August 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all units of the affected product. Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product. For questions regarding this recall call 732-542-2800.

Device

Grafton DBM Flex
  • Model / Serial
    Catalog Number A42150 Lot #OTSCT08 2845 exp 4/30/14 Catalog Number A4215000000000 Lot #OTSCT08 2845 exp 4/30/14
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution
  • Product Description
    Grafton DBM Flex; Unit Size 5x5 cm; 1ea || Container: Foil Pouch with Tyvek pouch || Fracture repair, bridge bone gaps or fragments, use with strut grafts
  • Manufacturer
    Osteotech Inc

Manufacturer

Osteotech Inc
  • Manufacturer Address
    Osteotech Inc, 51 James Way, Eatontown NJ 07724-2272
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA