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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device joint, knee, external limb component
Regulation Description External limb prosthetic component.
Product CodeISY
Regulation Number 890.3420
Device Class 1

Device Problems
Device operates differently than expected 2
Positioning Issue 1
Device handling issue 1
Total Device Problems 4

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 2 0 1 0 1 1 0 0 1 1
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 Dec-16-2009
2 Medi Manufacturing Inc II Apr-24-2007
3 Ossur II Jul-12-2007
4 Ossur Engineering, Inc II Mar-25-2011
5 Ossur H / F II Feb-06-2012
6 Otto Bock Healthcare GmbH II Feb-01-2016
7 Otto Bock Healthcare GmbH II Jul-24-2015

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