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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hook, surgical, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGDG
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 36
Degraded 7
Component(s), broken 4
Material disintegration 3
Fracture 2
Other (for use when an appropriate device code cannot be identified) 2
Detachment of device or device component 2
No Information 2
No code available 1
Device operates differently than expected 1
Device or device fragments location unknown 1
Material separation 1
Tip breakage 1
Detachment of device component 1
Material discolored 1
Total Device Problems 65

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

Recalls
Manufacturer Recall Class Date Posted
1 Telefelx Medical II Sep-04-2008
2 Teleflex Medical II Jan-11-2012

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