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
    22904
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-25
  • 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 canada is sending this reminder to provide important information concerning the proper use of altrus thermal tissue fusion handpieces. the reason for this notification is to reinforce best practices when using energy devices. energy based vessel sealing devices are vital in the continued improvement in surgical approaches. as with all energy based technologies there are risks. it is important to follow the defined instructions for use when handling these devices after they are activated. use caution and best practices as these devices generate heat. ensure the jaws of your energy based vessel sealing devices are not in contact with unintended tissue surfaces or objects until the jaws have cooled sufficiently. if the jaws are still hot there is a risk that a patient could be unintentionally burned if they have not cooled sufficiently. always refer to a device's operator's manual and instructions for use for proper use and warnings.

Device

ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Model / Serial
    Model Catalog: 60-9511-001 (Lot serial: All Lots); Model Catalog: 60-9512-001 (Lot serial: All Lots); Model Catalog: 60-9520-001 (Lot serial: All Lots); Model Catalog: 60-9521-001 (Lot serial: All Lots); Model Catalog: 60-9522-001 (Lot serial: All Lots); Model Catalog: 60-9510-001 (Lot serial: All Lots)
  • Product Description
    ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Manufacturer
    CONMED CANADA

Manufacturer

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