Events

Recall of CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator

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-2013-RN-00046-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00046-1
  • 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 notified by the manufacturer that since 2009 they have received a small number of complaints for cusa tip breakage. the manufacturer's investigation of these complaints identified that when the tips are used under specific circumstances with the cem nosecone, there is the potential for erosion of the cusa tip. the erosion can potentially lead to tip breakage.Specifically, the potential for cusa tip erosion occurs only during cem operation and if the side of the tip, rather than the annulus of the tip, is in contact with the tissue.
  • Action
    Integra Neurosciences Pty Ltd is revising the package insert to include an additional warning advising users to ensure that only the CEM Nosecone contacts the intended tissue at the annulus of the tip and not the side of the tip to avoid tip breakage.

Device

CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
  • Model / Serial
    CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic AspiratorCatalogue Numbers: C6623, C6636All lot numbers affectedARTG Number: 197945
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd