Events

Recall of HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-2014-RN-00200-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00200-1
  • 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
    Integra neurosciences has recently identified, through an internal evaluation, a risk of damage to the package (external pouch) of the hintegra total ankle prosthesis tibial and talar components during shipping/handling. this damage might lead to a breakage of the sterility barrier of this external pouch, thus posing the risk of a potential patient infection. the risk for an adverse patient consequence has been determined to be not likely based on the manufacturer’s health hazard evaluation.
  • Action
    Integra trained representatives will be performing an inspection of the affected components at the healthcare facility before each surgery by following a verified inspection process. This will assure that only products without damages external pouches are used in surgeries.

Device

HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)
  • Model / Serial
    HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)Multiple Catalogue Numbers affected All unexpired lotsARTG Number: 173960
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd