Recall Z-0209-2016 ยท ISH Component, External, Limb, Ankle/Foot
Otto Bock Healthcare GmbH
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
| Date | Nov 4, 2015 (initiated Oct 23, 2015) |
| Status | Terminated |
| Reason | A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration. |
| Root cause | Software design |
| Action | OttoBock sent an Urgent Medical Device Correction letter dated October 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The US Agent will notify US customers via letter on October 23, 2015, of the correction on behalf of the Manufacturer. Customers will be requested to contact all users and advise them of the hazards when operating machines or vehicles with foot pedals. They may forward a copy of the insert if needed. Customers will also be requested to contact all users with TF-fittings, where the settings w |
| Quantity | 273 in US: 48 Foreign |
| Distribution | Worldwide Distribution - US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.