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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device joint, ankle, external brace
Regulation Description Limb orthosis.
Product CodeITW
Regulation Number 890.3475
Device Class 1

Device Problems
No Known Device Problem 3
Device operates differently than expected 2
Fracture 2
Size incorrect for patient 1
Improper or incorrect procedure or method 1
Delamination 1
Naturally worn 1
Total Device Problems 11

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

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

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