The Recall Desk
CriticalFDA (Devices)·Z-2014-2012·Announced 2012-07-25

Etac Walker Recall Due to Wheel Detachment and Fall Risk

Etac Supply Center Ab is recalling Ono, Avant, and Salsa walkers because wheels may fall off, posing a risk of serious injury or death.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that one death occurred in a user fall incident, which mandates a Critical severity score of 5 according to the rubric.

Plain-English summary

Etac Supply Center Ab is recalling approximately 226,695 units of Etac Ono, Avant, and Salsa four-wheeled walkers. These devices are intended as walking aids for indoor and outdoor use for persons weighing up to 125 kg. The recall covers units distributed in the United States and numerous countries worldwide, including those in Europe, Asia, and the Middle East.

The recall was initiated because there is a potential for users to fall and become injured if a wheel falls off the walker. The hazard includes the potential for serious injury, such as bone fractures. Etac has received 49 reports from Europe and Japan regarding wheels falling off. One death occurred in a user fall incident, although it is unclear whether the fall was caused by the loss of a wheel.

Consumers should stop using the affected walkers immediately. The specific model numbers involved in this recall are 15030102-15, 15030103-15, 15030202-15, 15030403-15, 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Etac Supply Center Ab

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