FDA Enforcement Class II Terminated

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.

Recall: Z-2014-2012 · Reported July 25, 2012

Enforcement

Recall Number
Z-2014-2012
Event ID
61463
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Etac Supply Center Ab
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
July 25, 2012
Initiation Date
April 6, 2012
Classification Date
July 14, 2012
Termination Date
June 18, 2013
Address
Langgatan 12, Anderstorp, N/A, Sweden

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.

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

Code Info

Model numbers: 15030102-15, 15030103-15 , 15030202-15, 15030403-15 , 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18.

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.

Quantity

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