Events

Recall of ACTIFUSE ABX Synthetic Bone Substitute (artifical bone graft)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

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-00853-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00853-3
  • 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
    There have been isolated reports of postoperative fever and inflammatory reactions (in the absence of bacterial infection) with use of actifuse abx in paediatric patients undergoing surgical removal of large juvenile bone cysts. the reported side effects had no negative impact on therapeutic outcome or function of the actifuse product. the instructions for use will be updated to include the reported problems as precautionary statement.
  • Action
    Updated Instructions for Use (IFU) is being provided to all users of the affected devices.

Device

ACTIFUSE ABX Synthetic Bone Substitute (artifical bone graft)
  • Model / Serial
    ACTIFUSE ABX Synthetic Bone Substitute (artifical bone graft)All lot numbersARTG Number : 188736
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd