Reported Nov 11, 2015 · Terminated
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an…
Otto Bock Healthcare GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Otto Bock Healthcare GmbH · Max-Nader-Str. #15 · Duderstadt, N/A · N/A
Is this the product you have?
- iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
- Lot codes and dates
- 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/01C66=L26-1-P/0 201507006 1C66=L26-2-P/0
201448018201449039201507007201507008201507017201514033201518007201528008
1C66=L26-3-P/0201444038201444039201444043201444046201444048201449038201507009201507015201507019201528021201528025
1C66=L26-3-P/0201444004201444014201444037201444040201444047201444049201449001201449004201504007201504011201504020201518026
1C66=L27-2-P/0 201448012 201448020 201449008 201449013 201449027 201449030 201523027 1C66=L27-3-P/0201518027201518029201518030201518031201523011201523018201523028201523035201523043201523045201523048201529003201529009201529010201529014201529027201529028
1C66=L27-3-P/0 201529015 201529017 201538031 1C66=L28-2-P/0 201507026 1C66=L28-3-P/0201444003201444007201444024201444031201444032201444035201444036201444044201449017201449019201449024201449032201449033201504016201504018201504019201504021201504028201518001201518010201518011201518022201518041201523020201528001201528004201528013201528019201528023201529005201529008201529013
1C66=L29-2-P/0 201507021 1C66=L29-3-P/0201448022201448023201448027201449037201507027201507028201507029201507030201529040201538014
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/0201448007201448008201514001201518013201518024201528007201528022201529023201529024
1C66=R25-2-P/0 201448006 201448009 201504004 201507032 201518016 201518043 1C66=R25-3-P/0201448001201507024201507025201518042201523047201528010201528014201529018201529033
1C66=R25-3-P/0 201518036 201518049 201523013 201523032 201523034 1C66=R26-1-P/0 201448002 201504006 1C66=R26-2-P/0201448003201448004201448005201504003201504015201504024201514011201514038201518021
1C66=R26-3-P/0201444002201444008201444025201444028201504009201504013201504026201504027201507016201507023201523024
1C66=R27-2-P/0201448042201448043201448045201448050201504012201504017201504022201504023201504030201507013201507014201507020201518002201518018201518047201523004201523010201523014201523016201523025201523030201523049201523050201529031201529039201538024201538033201538034
1C66=R27-2-P/0 201523031 201529034 1C66=R27-3-P/0201448033201448035201448036201448040201449023201504014201518014201518032201518045201518050
1C66=R28-2-P/0 201507033 201510019 201518033 201523040 201529032 1C66=R28-3-P/0201444010201444015201444016201444017201444023201444027201444029201444034201449005201449009201449021201449026201449031201449035201449040201518017201518023201523003201523005201523006201523017201523026201523033201529019201529045
1C66=R29-2-P/0 201507018 1C66=R29-3-P/0201448029201448034201448039201449002201449010201449014201449022201449036201518009201518039201529020
201448041201507010201514002201514020201518037201523038201528009201529002201529026
- 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
- Amount recalled
- 273 in US: 48 Foreign
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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