• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device gauge, depth
Regulation Description Depth gauge for clinical use.
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

Device Problems
Break 125
Material fragmentation 39
Component missing 21
Device operates differently than expected 18
Incorrect measurement 16
Mechanical jam 12
Bent 10
Sticking 10
Device Cleaning Issue 4
Fitting problem 3
Naturally worn 2
Misassembled 2
Material separation 2
Display misread 2
Calibration issue 2
Detachment of device or device component 2
Device markings issue 1
Dull 1
Failure to align 1
Metal shedding debris 1
Detachment of device component 1
Material discolored 1
Total Device Problems 276

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

-
-