Events

Recall of Kryptonite Bone Cement

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Doctor's Research Group, 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
    61709
  • Event Risk Class
    Class 2
  • Event Number
    Z-1496-2012
  • Event Initiated Date
    2012-04-06
  • Event Date Posted
    2012-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108767
  • 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
    Methyl methacrylate for cranioplasty - Product Code GXP
  • Reason
    Bone cement strength and stiffness fall below specification at body temperature.
  • Action
    Doctors Research Group (DRG) issued a Voluntary Product Recall Notification letter dated April 2012 to all affected customers via email or Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify, segregate and return any affected products in their possession. Customers were asked to fill out and return the enclosed verification form Distributors were requested to notify their customers. For questions contact DRG at 203-262-9335.

Device

Kryptonite Bone Cement
  • Model / Serial
    All Lot Codes within expiration date distributed between January 2010 through April 2012.  Lot Numbers: 02120422; 03092011; 05042011; 08112011; 04062011; 04072011; 08102011; 01162012
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: || Product Codes: || KRYP-US-Z-05 (5cc Kit) || KRYP-US-Z -10 (10cc Kit) || Product Usage: || Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects
  • Manufacturer
    Doctor's Research Group, Inc.

Manufacturer

Doctor's Research Group, Inc.
  • Manufacturer Address
    Doctor's Research Group, Inc., 574 Heritage Rd, Southbury CT 06488-1868
  • Source
    USFDA