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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, cutting, orthopedic
Regulation Description Manual surgical instrument for general use.
Product CodeHTZ
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 14
Material fragmentation 3
Fracture 2
Detachment of device or device component 2
Mechanical jam 2
Device operates differently than expected 1
Pitted 1
Sticking 1
Tip breakage 1
Component missing 1
Total Device Problems 28

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jan-13-2009
2 Synthes, Inc. II Jun-11-2014
3 The Anspach Effort, Inc. II Aug-05-2015
4 Tornier, Inc II Sep-13-2013

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