Recall Z-2014-2012— Etac Supply Center Ab
Class II · Terminated
Class II FDA medical device recall by Etac Supply Center Ab, initiated 2012-04-06, terminated 2013-06-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- Etac Supply Center Ab
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-06
- Terminated
- 2013-06-18
- Firm location
- Anderstorp, Sweden
Product 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 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.