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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assembly, knee/shank/ankle/foot, external
Regulation Description External assembled lower limb prosthesis.
Product CodeISW
Regulation Number 890.3500
Device Class 2

Device Problems
Device operates differently than expected 9
Unknown (for use when the device problem is not known) 3
Solder joint failure 2
Battery issue 1
Tube(s), defective 1
Loss of or failure to bond 1
Electrical issue 1
Inadequate service 1
No Known Device Problem 1
Device misassembled during manufacturing or shipping 1
Material fragmentation 1
Material Protrusion 1
Manufacturing or shipping issue associated with device 1
Mechanical issue 1
Total Device Problems 25

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ability Dynamics LLC II Jun-18-2014
2 Ossur H / F II Mar-25-2015
3 Otto Bock Healthcare Product II Aug-21-2015
4 iwalk inc II Dec-04-2012

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