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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 6
Failure to fire 3
Unknown (for use when the device problem is not known) 3
Component missing 1
Dull 1
Failure to form staple 1
Device operates differently than expected 1
Difficult to deploy 1
Use of Device Issue 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 1 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon Endo-Surgery Inc II Aug-25-2008
2 Maquet Cardiovascular II Feb-11-2011

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