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U.S. Department of Health and Human Services

Class 2 Device Recall Etac Ono, Avant, and Salsa Walkers

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  Class 2 Device Recall Etac Ono, Avant, and Salsa Walkers see related information
Date Initiated by Firm April 06, 2012
Date Posted July 14, 2012
Recall Status1 Terminated 3 on June 18, 2013
Recall Number Z-2014-2012
Recall Event ID 61463
Product Classification Walker, mechanical - Product Code ITJ
Product 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.
Code Information Model numbers: 15030102-15, 15030103-15 , 15030202-15, 15030403-15 , 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18. 
Recalling Firm/
Manufacturer		 Etac Supply Center Ab
Langgatan 12
Anderstorp Sweden
For Additional Information Contact
855-2777470
Manufacturer 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
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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