Events

Recall of TRITON SMART ANKLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OTTO BOCK HEALTHCARE CANADA 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
    44234
  • Event Risk Class
    III
  • Event Initiated Date
    2015-10-26
  • 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
    When sitting the prosthetic foot can go into the 'relief function' to move the footplate towards the ground if this function is not switched off or if the foot is in stand-by mode. when operating machines with foot pedals the possibility is given that the foot - unnoticed by the user - activates the 'relief function' and for example get stuck under the foot pedal. the foot pedal can be blocked and this could lead to a hazardous situation. also an ios software issue has been identified where the restricted range for dorsiflexion in the 'relief function' does not save when the re-training is done via ios galileo application.

Device

TRITON SMART ANKLE

Manufacturer

OTTO BOCK HEALTHCARE CANADA LTD.