Class 2 Device Recall Triton Smart Ankle

• Date Initiated by Firm: October 23, 2015
• Date Posted: November 04, 2015
• Recall Status: Terminated on March 21, 2017
• Recall Number: Z-0209-2016
• Recall Event ID: 72488
• Product Classification: Component, external, limb, ankle/foot - Product Code ISH
• 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.
• Code Information: 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 201504007 201504011 201504020 201518026 1C66=L26-3-P/0 201518027 201518029 201518030 201518031 201523011 201523018 201523028 201523035 201523043 201523045 201523048 201529003 201529009 201529010 201529014 201529027 201529028 1C66=L27-2-P/0 201448012 201448020 201449008 201449013 201449027 201449030 201523027 1C66=L27-3-P/0 201444003 201444007 201444024 201444031 201444032 201444035 201444036 201444044 201449017 201449019 201449024 201449032 201449033 201504016 201504018 201504019 201504021 201504028 201518001 201518010 201518011 201518022 201518041 201523020 201528001 201528004 201528013 201528019 201528023 201529005 201529008 201529013 1C66=L27-3-P/0 201529015 201529017 201538031 1C66=L28-2-P/0 201507026 1C66=L28-3-P/0 201448022 201448023 201448027 201449037 201507027 201507028 201507029 201507030 201529040 201538014 1C66=L29-2-P/0 201507021 1C66=L29-3-P/0 201448007 201448008 201514001 201518013 201518024 201528007 201528022 201529023 201529024 1C66=R22-1-P/0 201516013 1C66=R23-1-P/0 201508008 201508020 201525039 1C66=R23-2-P/0 201508009 201508012 1C66=R24-2-P/0 201508016 201525026 1C66=R25-1-P/0 201448001 201507024 201507025 201518042 201523047 201528010 201528014 201529018 201529033 1C66=R25-2-P/0 201448006 201448009 201504004 201507032 201518016 201518043 1C66=R25-3-P/0 201448003 201448004 201448005 201504003 201504015 201504024 201514011 201514038 201518021 1C66=R25-3-P/0 201518036 201518049 201523013 201523032 201523034 1C66=R26-1-P/0 201448002 201504006 1C66=R26-2-P/0 201444002 201444008 201444025 201444028 201504009 201504013 201504026 201504027 201507016 201507023 201523024 1C66=R26-3-P/0 201448042 201448043 201448045 201448050 201504012 201504017 201504022 201504023 201504030 201507013 201507014 201507020 201518002 201518018 201518047 201523004 201523010 201523014 201523016 201523025 201523030 201523049 201523050 201529031 201529039 201538024 201538033 201538034 1C66=R27-2-P/0 201448033 201448035 201448036 201448040 201449023 201504014 201518014 201518032 201518045 201518050 1C66=R27-2-P/0 201523031 201529034 1C66=R27-3-P/0 201444010 201444015 201444016 201444017 201444023 201444027 201444029 201444034 201449005 201449009 201449021 201449026 201449031 201449035 201449040 201518017 201518023 201523003 201523005 201523006 201523017 201523026 201523033 201529019 201529045 1C66=R28-2-P/0 201507033 201510019 201518033 201523040 201529032 1C66=R28-3-P/0 201448029 201448034 201448039 201449002 201449010 201449014 201449022 201449036 201518009 201518039 201529020 1C66=R29-2-P/0 201507018 1C66=R29-3-P/0 201448041 201507010 201514002 201514020 201518037 201523038 201528009 201529002 201529026
• Recalling Firm/ Manufacturer: Otto Bock Healthcare GmbH; Max-Nader-Str. #15; Duderstadt Germany
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 were done via iOS Galileo app., inform the user about this issue, and assure that settings in the device are as expected.The customer will be requested to complete a reply form and return to the US Agent. For further questions call (800) 328-4058.
• Quantity in Commerce: 273 in US: 48 Foreign
• Distribution: Worldwide Distribution - US (nationwide) and to the countries of : Austria, Belgium, Germany, Israel, Luxembourg and Sweden.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.