FDA Device recall Z-0209-2016

iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle

FDA Device
Class II
terminated
Published 2015-11-11

On 2015-11-11 the FDA classified a Class II recall of iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle by Otto Bock Healthcare, citing 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 foo….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0209-2016
Classification	Class II
Status	terminated
Initiated	2015-10-23
Published	2015-11-11
Last updated	2026-09-13 11:53 UTC
Company	Otto Bock Healthcare
Distribution	US

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.

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.

Identifiers

code_info	The devices in US distribution were manufactured between 29 September 2014 and 19 September 2015. Material… The devices in US distribution were manufactured between 29 September 2014 and 19 September 2015. Material Serialnumber 1C66=L22-2-P/0 201516011 1C66=L23-1-P/0 201525027 1C66=L23-2-P/0 201516014 201516016 201525022 1C66=L24-1-P/0 201516006 201516019 201525007 1C66=L24-2-P/0 201516002 201525012 201525020 1C66=L25-1-P/0 201449025 201518040 1C66=L25-2-P/0 201448015 201448019 201449020 201449034 201507001 201507005 201523037 1C66=L25-3-P/0 201448018 201449039 201507007 201507008 201507017 201514033 201518007 201528008 1C66=L26-1-P/0 201507006 1C66=L26-2-P/0 201444038 201444039 201444043 201444046 201444048 201449038 201507009 201507015 201507019 201528021 201528025 1C66=L26-3-P/0 201444004 201444014 201444037 201444040 201444047 201444049 201449001 201449004 2

code_info

The devices in US distribution were manufactured between 29 September 2014 and 19 September 2015. Material…

The devices in US distribution were manufactured between 29 September 2014 and 19 September 2015. Material Serialnumber 1C66=L22-2-P/0 201516011 1C66=L23-1-P/0 201525027 1C66=L23-2-P/0 201516014 201516016 201525022 1C66=L24-1-P/0 201516006 201516019 201525007 1C66=L24-2-P/0 201516002 201525012 201525020 1C66=L25-1-P/0 201449025 201518040 1C66=L25-2-P/0 201448015 201448019 201449020 201449034 201507001 201507005 201523037 1C66=L25-3-P/0 201448018 201449039 201507007 201507008 201507017 201514033 201518007 201528008 1C66=L26-1-P/0 201507006 1C66=L26-2-P/0 201444038 201444039 201444043 201444046 201444048 201449038 201507009 201507015 201507019 201528021 201528025 1C66=L26-3-P/0 201444004 201444014 201444037 201444040 201444047 201444049 201449001 201449004 2

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0209-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.