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Class 2 Device Recall Etac Ono, Avant, and Salsa Walkers |
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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
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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
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For Additional Information Contact |
855-2777470
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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
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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
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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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