Events

Recall of LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device

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-2017-RN-00405-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00405-1
  • 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
    Advanced medical solutions (ams) extended claims in the instructions for use of liquiband fix8 in may 2015 from "laparoscopic surgical repair of inguinal hernia, achieved through the fixation of polypropylene or polypropylene / polyester combination hernia mesh to the abdominal wall" to "laparoscopic repair of abdominal hernias, achieved through the fixation of prosthetic mesh to the abdominal wall and the approximation of peritoneum". a recent technical file audit by the notified body bsi has revealed that more data was required to support these extended claims. until further notice, the fix8 device should only be used as per the original instructions for use, version drm 06 0528 01 (revision 1).
  • Action
    AMS is providing users with revision 1 of the IFU that is to be used with stock that has been purchased and is currently in stock. Future shipments of the device will be shipped with IFU revision 1 until further notice.

Device

LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device
  • Model / Serial
    LiquiBand FIX8 Hernia Mesh Adhesive Fixation DeviceProduct Code: FX001ARTG Number: 233374
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd