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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 brace
Regulation Description Limb orthosis.
Product CodeITQ
Regulation Number 890.3475
Device Class 1


Premarket Reviews
ManufacturerDecision
AIRCAST, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATION SPORTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 6
No Information 2
Patient-device incompatibility 2
Buckled material 1
Device operates differently than expected 1
Material deformation 1
Break 1
Detachment of device component 1
User used incorrect product for intended use 1
Use of Device Issue 1
No code available 1
Total Device Problems 18

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

Recalls
Manufacturer Recall Class Date Posted
1 Corflex II Jan-04-2016
2 Ossur H / F II Mar-31-2016
3 United Surgical Associates II May-23-2015

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