Events

Recall of Kasios TCP and KagesKasios TCP, Kage, RSF, Wedge Kage, TLIF Kage RSF

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life 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-2016-RN-01443-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01443-1
  • 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
    An issue has been identified during the validation verification of the sterilisation procedures. there is a risk in connection to sterilisation conformity for specific batches. this could lead to an increased risk of infection in the days following surgery. no adverse event has been reported worldwide in relation to this issue.
  • Action
    Life Healthcare is advising surgeons to review their patients who have been implanted with the affected products for any post-operative infection.

Device

Kasios TCP and KagesKasios TCP, Kage, RSF, Wedge Kage, TLIF Kage RSF
  • Model / Serial
    Kasios TCP and KagesKasios TCP, Kage, RSF, Wedge Kage, TLIF Kage RSFMultiple Item and Lot NumbersARTG Numbers: 192697, 186610, 141918, 178660
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd