Events

Recall of ArthroCare Corporation HipVac 50 Coblation Wand

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Arthrocare Australasia 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-01203-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01203-1
  • 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
    Based on internal investigation, arthrocare has confirmed that the packaging tray that houses the hipvac wand may have been damaged, which could result in a breach of the sterile barrier. this failure was discovered during final inspection.
  • Action
    Customers are requested to Immediately discontinue use of the HipVac Wand immediately and take steps to quarantine the devices. If affected product is identified, Smith & Nephew Surgical Customer Service will be in contact with customers once the disposition form is returned, to arrange for the product to be returned and suggest alternate products. This action has been closed-out on 06/07/2016.

Device

ArthroCare Corporation HipVac 50 Coblation Wand
  • Model / Serial
    ArthroCare Corporation HipVac 50 Coblation WandModel Number: ASHA4730-01ARTG number: 221504
  • Manufacturer
    Arthrocare Australasia Pty Ltd

Manufacturer

Arthrocare Australasia Pty Ltd