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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps
Regulation Description Manual surgical instrument for general use.
Product CodeHTD
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 89
Device operates differently than expected 32
Material fragmentation 14
Component missing 10
Failure to Adhere or Bond 7
Detachment of device component 5
Detachment of device or device component 5
Naturally worn 4
Loose or intermittent connection 4
Fracture 4
Bent 3
Blockage within device or device component 2
Failure to capture 2
Device damaged prior to use 2
Device inoperable 2
No Information 2
No code available 2
Failure to advance 2
Device or device fragments location unknown 2
Patient-device incompatibility 1
Failure to separate 1
Device Issue 1
Failure to align 1
Metal shedding debris 1
Melted 1
Loss of power 1
Product quality issue 1
Slippage of device or device component 1
Coiled 1
Component falling 1
Corrosion 1
Failure to deploy 1
Dissection 1
Total Device Problems 207

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2013
2 Edwards Lifesciences, LLC III Dec-21-2013
3 Stryker Howmedica Osteonics Corp. III Dec-16-2009
4 Synthes USA (HQ), Inc. II Oct-26-2009
5 Telefelx Medical II Nov-29-2007

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