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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pliers, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeHTC
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 28
Material fragmentation 7
Component missing 5
Device or device fragments location unknown 3
Bent 2
Device inoperable 1
Detachment of device or device component 1
Device operates differently than expected 1
Difficult to open or close 1
Dislodged or dislocated 1
Naturally worn 1
Device Cleaning Issue 1
Component(s), broken 1
Detachment of device component 1
Component falling 1
Total Device Problems 55

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

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Jan-07-2015
2 Synthes USA (HQ), Inc. II Oct-26-2009
3 The Anspach Effort, Inc. II Feb-03-2016

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