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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gauge, depth
Regulation Description Depth gauge for clinical use.
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

Device Problems
Break 60
Material fragmentation 18
Component missing 12
Sticking 9
Device operates differently than expected 7
Mechanical jam 6
Incorrect measurement 6
Bent 6
Display misread 2
Misassembled 2
Detachment of device or device component 2
Device markings issue 1
Metal shedding debris 1
Fitting problem 1
Detachment of device component 1
Material discolored 1
Total Device Problems 135

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 1 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 Stryker Howmedica Osteonics Corp. II Mar-31-2011
2 Stryker Howmedica Osteonics Corp. II Feb-19-2010

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