Events

Recall of Etac Ono, Avant, and Salsa Walkers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Etac Supply Center Ab.

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
    61463
  • Event Risk Class
    Class 2
  • Event Number
    Z-2014-2012
  • Event Initiated Date
    2012-04-06
  • Event Date Posted
    2012-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108163
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Walker, mechanical - Product Code ITJ
  • 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. among the walkers distributed worldwide, etac¿ has received a total of 49 reports from europe and japan of wheels falling.
  • Action
    Etac sent an "URGENT DEVICE RECALL " letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue selling and distributing the affected product. A Reply Postcard was enclosed for customers to complete and return. Contact the firm at 847-277-7705 for questions regarding this recall.

Device

Etac Ono, Avant, and Salsa Walkers
  • Model / Serial
    Model numbers: 15030102-15, 15030103-15 , 15030202-15, 15030403-15 , 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, China, Colombia, Germany, Denmark, Estonia, Spain, Finland, France, Great Brittain, Greenland, Greece, Hungaria, Ireland, Israel, Iceland, Italy, Japan, South Korea, Kuwait, Lithuania, Luxembourg, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Rumania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, and Thailand.
  • Product Description
    Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. || These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
  • Manufacturer
    Etac Supply Center Ab

Manufacturer

Etac Supply Center Ab
  • Manufacturer Address
    Etac Supply Center Ab, Langgatan 12, Anderstorp Sweden
  • Manufacturer Parent Company (2017)
    Nordstjernan Ab
  • Source
    USFDA