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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 188
Material fragmentation 43
Component missing 30
Device operates differently than expected 25
Incorrect measurement 16
Sticking 15
Mechanical jam 13
Bent 12
Detachment of device or device component 6
Fitting problem 6
Device Cleaning Issue 4
Failure to align 3
Calibration issue 2
Naturally worn 2
Misassembled 2
Material separation 2
Display misread 2
Fracture 2
Metal shedding debris 1
Device contamination with blood or blood product 1
Dull 1
Difficult to position 1
Material rigid or stiff 1
Detachment of device component 1
Component falling 1
Material discolored 1
Packaging issue 1
No code available 1
Device markings issue 1
Total Device Problems 384

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 1 1 0 0 0 0 0 0
Class III 0 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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