FDA-Device2012-07-25Class II
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.
Etac Supply Center Ab
Hazard
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
Sold states
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.
Affected count
204,323 units of the Etac Ono Walker, 15,601 units of the Etac Avant Walker, and 6,771 units of the ETAC Salsa Walker
Manufactured in
Langgatan 12, Anderstorp, Sweden
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2014-2012Don't want to check this manually?
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