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.
FDA Recall Z-2014-2012 · Posted 2012-07-14
Advertisement
Recalling FirmEtac Supply Center Ab
Recall StatusTerminated
Product CodeITJ
Date Initiated2012-04-06
Date Terminated2013-06-18
Product Quantity204,323 units of the Etac Ono Walker, 15,601 units of the Etac Avant Walker, and 6,771 units of the ETAC Salsa Walker
Reason for Recall
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement