Otto Bock Triton Smart Ankle Recalled Due to Software Issue
Otto Bock is recalling the Triton Smart Ankle and iOS Galileo app due to a software issue that can cause unexpected foot movement, posing a fall risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (prosthetic limb) where injury (falls, vehicle accidents) has not yet been reported, fitting the 'High' severity criteria for theoretical hazards.
Plain-English summary
Otto Bock Healthcare GmbH is recalling the 1C66 Triton Smart Ankle, an external prosthetic ankle/foot, and the iOS Galileo Application Version 1.1.1 or lower used to program it. The recall affects 273 units in the United States and 48 units in foreign countries, including Austria, Belgium, Germany, Israel, Luxembourg, and Sweden. The devices were manufactured between September 29, 2014, and September 19, 2015.
The recall is due to a software issue that can cause the prosthetic foot to move into dorsiflexion without the user noticing, which could lead to a fall. Additionally, when the user is sitting, the foot may enter a "Relief Function" that moves the footplate toward the ground. This movement can cause the foot to get stuck under foot pedals in vehicles, potentially blocking the pedal or causing unintended vehicle acceleration if the foot is on the pedal.
Consumers who have the affected Triton Smart Ankle or the iOS Galileo Application should contact Otto Bock Healthcare GmbH for instructions on how to resolve the issue. The company is the recalling firm for this action.
The recalled product
- Product
- iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
- Manufacturer
- Otto Bock Healthcare GmbH
- Category
- Medical Device — Prosthetic Limb
Distribution
Distributed nationwide across the United States.
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