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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handle, scalpel
Regulation Description Manual surgical instrument for general use.
Product CodeGDZ
Regulation Number 878.4800
Device Class 1

Device Problems
Break 4
Device handling issue 2
Use of Device Issue 2
Deployment issue 1
Device-device incompatibility 1
No Information 1
Handpiece break 1
Premature deployment 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 Ansell Sandel Medical Industries LLC II Jan-08-2014
2 Bard Access Systems II Apr-14-2015
3 Integra York PA, Inc II May-31-2016

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