Events

Recall of ACHILLON Minimally Invasive Achilles Tendon Suture System

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-2016-RN-00825-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00825-1
  • 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
    Internal investigation by the manufacturer has identified that there is the possibility that one section of the outer package tyvek seal for the achillon suture system may not remain completely sealed if not used within its shelf-life of 5 years. the section of the seal affected is adjacent to the finger-lift used to open the outer blister and were it to occur the sterility assurance of the exterior surface of the inner package may be compromised. to date, no instances have been reported.
  • Action
    Customers are requested to review their inventory and stop using the affected products immediately. Integra Neurosciences will advise customers on how to return the affected stock and provide credit or replacement products. This action has been closed-out on 10/05/2017.

Device

ACHILLON Minimally Invasive Achilles Tendon Suture System
  • Model / Serial
    ACHILLON Minimally Invasive Achilles Tendon Suture SystemCatalogue Number: 119700NDAll Lot Numbers affectedARTG Number: 173933
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd