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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rasp
Regulation Description Manual surgical instrument for general use.
Product CodeHTR
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 13
Break 10
Fitting problem 10
Device, or device fragments remain in patient 4
Use of Device Issue 4
Device markings issue 4
Device, removal of (non-implant) 3
Malfunction 2
Detachment of device component 2
Device operates differently than expected 2
No code available 2
Material deformation 1
No Information 1
Crack 1
Entrapment of device or device component 1
Material fragmentation 1
Loose or intermittent connection 1
Misassembled 1
Device remains implanted 1
Failure to Adhere or Bond 1
Connection issue 1
Tear, rip or hole in device packaging 1
Total Device Problems 67

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

Recalls
Manufacturer Recall Class Date Posted
1 Sterilmed Inc II Jan-13-2009
2 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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