Events

Recall of Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000

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-2017-RN-01276-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01276-1
  • 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 been advised that certain lots of footswitch supplied with the cusa clarity console may be faulty.A faulty footswitch may result in unintended ultrasonic fragmentation activation. there are two scenarios during which the failure mode may occur:1. ultrasonic fragmentation may be activated after set-up is complete and the user goes to the main screen (without the footswitch pressed); and/or2. ultrasonic fragmentation may remain activated during surgical use once the footswitch amplitude pedal is disengaged.There have been no adverse events or injury reported.
  • Action
    Integra is advising users to quarantine the affected units from use. Affected units will be replaced with unaffected stock.

Device

Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000
  • Model / Serial
    Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000Catalogue Number: C7002Lot Numbers: 1885744, 1923802, 1985221, 2057996, 2109587 and 2118507ARTG Number: 283158
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd