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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device component, external, limb, ankle/foot
Regulation Description External limb prosthetic component.
Product CodeISH
Regulation Number 890.3420
Device Class 1


Premarket Reviews
ManufacturerDecision
NOBLE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component incompatible 2
Electro-magnetic interference (EMI) 1
Defective item 1
Break 1
Detachment of device component 1
Total Device Problems 6

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 3 0 0 0 0 1 1 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Composite Technology II Aug-07-2007
2 College Park Industries, Inc. II May-23-2012
3 Ossur II Jan-10-2007
4 Ossur Americas, Inc. II Feb-06-2014
5 Ossur H / F II Mar-17-2015
6 Ossur North America Inc II Nov-19-2013
7 Otto Bock Healthcare GmbH II Nov-04-2015
8 Southern Prosthetic Supply Co. II Jan-10-2007

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