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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, tumor localization
Regulation Description Manual surgical instrument for general use.
Product CodeMIJ
Regulation Number 878.4800
Device Class 1

Device Problems
Break 3
Melted 1
Material separation 1
No Known Device Problem 1
Total Device Problems 6

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Feb-29-2016

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