Events

Recall of Kryptonite Bone Cement / Kryptonite X-Radiopaque Bone Cement (Intended for use as a self-setting bone void filler for bony voids or gaps that are no intrinsic to the stability of the bony structure)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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
    RC-2012-RN-01038-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01038-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Several recent modifications have been made to the instructions for use including updates to product warnings and storage requirements.
  • Action
    The sponsor is providing updated Instructions for Use (IFU) is being provided to the customers.

Device

Kryptonite Bone Cement / Kryptonite X-Radiopaque Bone Cement (Intended for use as a self-setting ...
  • Model / Serial
    Kryptonite Bone Cement / Kryptonite X-Radiopaque Bone Cement (Intended for use as a self-setting bone void filler for bony voids or gaps that are no intrinsic to the stability of the bony structure)Model numbers: KRYP-Z-10 & KRYP-Z-05All serial numbers and lot numbers produced within the last 18 monthsARTG Number: 147863
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia