Events

Recall of APEX Arthroscopy Tubing Set, One Connection

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConMed Linvatec Australia 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-00558-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00558-1
  • 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
    The manufacturer has advised that a problem with a component in the apex tubing may cause an unexpected increase in fluid flow to the surgical site, due to a failure to sense pressure correctly.
  • Action
    ConMed Linvatec is requesting their customers to return all affected tubing sets. A credit note will be provided for returned stock.

Device

APEX Arthroscopy Tubing Set, One Connection
  • Model / Serial
    APEX Arthroscopy Tubing Set, One ConnectionLot numbers: 1301184 to 1305054Reference number: C7120ARTG number: 128582
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd