Events

Recall of 5 INCH WHEEL KIT FOR WALKER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUNRISE MEDICAL 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
    148625
  • Event Risk Class
    II
  • Event Initiated Date
    2006-08-15
  • 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
    Defective wheels on wheeled walker. the cause was that the wheel hub thickness went from 5mm to 4mm. this change causes some hubs to fracture due to side impact or heavy weight leaning to one side of walker.

Device

5 INCH WHEEL KIT FOR WALKER
  • Model / Serial
    Model Catalog: (Lot serial: 07722-8); Model Catalog: (Lot serial: 07722-5); Model Catalog: (Lot serial: 07725); Model Catalog: (Lot serial: 07722G); Model Catalog: (Lot serial: 30757WB); Model Catalog: (Lot serial: 30751W); Model Catalog: (Lot serial: 30757W); Model Catalog: (Lot serial: 30758W)
  • Product Description
    5in wheels kits
  • Manufacturer
    SUNRISE MEDICAL CANADA INC.

Manufacturer

SUNRISE MEDICAL CANADA INC.