Events

Recall of ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CONMED CANADA.

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
    138943
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Conmed corporation confirmed that two lots of altrus thermal tissue fusion handpiece devices were exposed to a higher than acceptable level of particulate matter during manufacture in march 2013. device sterility and performance are unaffected by this exposure. these lots were released for distribution without following the specific documentation requirements of conmed electrosurgery to place the affected products on non-conformance report prior to disposition. in october 2013 conmed notified the usfda of their intent to recall altrus thermal tissue fusion handpieces catalog no. 60-9520-001 lot 13chb007 and 60-9522-001 lot 13chb006 due to exposure to high particle count during manufacture. only catalog no. 60-9522-001 lot 13chb006 was distributed in canada.

Device

ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Model / Serial
    Model Catalog: 60-9522-001 (Lot serial: 13CHB006)
  • Product Description
    ALTRUS Thermal Tissue Fusion Handpieces
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC