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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

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 1 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bock,Otto,Orthopedic Ind,Inc II Jan-25-2007
2 LeMaitre Vascular, Inc. II Apr-04-2013

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