Etac Ono Walker, Etac Avant Walker, and Etac Salsa Walker. These products are four-wheeled walkers intended as a walking

FDA device recall Z-2014-2012 · posted 2012-07-14 · Terminated

Recall details

Recalling firm

Etac Supply Center Ab

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

Action taken

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

Status

Terminated

Product code

ITJ

Quantity affected

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

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,

Date initiated

2012-04-06

Date posted

2012-07-14

Date terminated

2013-06-18

Location

Anderstorp, Sweden