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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device component, traction, invasive
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeJEC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  1
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
SYNTHES
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 3
Failure to deploy 2
Electro-magnetic interference (EMI) 1
Material fragmentation 1
Device maintenance issue 1
Mechanical issue 1
Device remains activated 1
Sticking 1
Defective component 1
Component missing 1
Implant, removal of 1
Detachment of device or device component 1
Not Applicable 1
Component(s), broken 1
Difficult to deploy 1
Total Device Problems 18

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

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Mar-16-2010
2 Stryker Howmedica Osteonics Corp. II Sep-16-2008

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