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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
Fracture 4
Break 3
Detachment of device component 2
Device damaged prior to use 2
Blockage within device or device component 2
Failure to advance 2
Device Issue 1
Melted 1
Device inoperable 1
Dissection 1
Coiled 1
Total Device Problems 20

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 1 0 0 0 0
Class III 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. III Dec-16-2009
2 Synthes USA (HQ), Inc. II Oct-26-2009
3 Telefelx Medical II Nov-29-2007

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