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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tap, bone
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWX
Regulation Number 888.4540
Device Class 1

Device Problems
Break 88
Fracture 13
Material fragmentation 8
Material frayed 5
Crack 4
Tip breakage 4
Use of Device Issue 4
No Known Device Problem 3
Bent 3
Device, or device fragments remain in patient 2
Device operates differently than expected 2
Material deformation 1
Mechanical jam 1
Device damaged prior to use 1
Component missing 1
Split 1
Device, removal of (non-implant) 1
Detachment of device component 1
Migration of device or device component 1
Device remains implanted 1
Total Device Problems 145

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 1 2 0 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Blackstone Medical, Inc. II May-19-2010
2 Orthohelix Surgical Designs Inc II Nov-26-2010
3 Smith & Nephew Inc II Jun-06-2012
4 Sterilmed Inc II Jan-13-2009
5 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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