Events

Recall of ROLLATOR AVANT MED KORG

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

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
    26547
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-14
  • 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
    The recall has been initiated because there is the potential that users may fall and become injured with the potential for serious injury including bone fracture. one death occurred in a user fall incident but it is unclear whether the fall was caused by the loss of a wheel.

Device

ROLLATOR AVANT MED KORG
  • Model / Serial
    Model Catalog: 15030102-15 (Lot serial: N/A); Model Catalog: 15040301-14 (Lot serial: N/A); Model Catalog: 15040105-33 (Lot serial: N/A); Model Catalog: 15040105-14 (Lot serial: N/A); Model Catalog: 15030202-15 (Lot serial: N/A); Model Catalog: 15040108-33 (Lot serial: N/A)
  • Product Description
    AVANT WHEELED WALKER
  • Manufacturer
    PERFORMANCE HEALTH CANADA INC.

Manufacturer

PERFORMANCE HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC