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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, needle
Regulation Description Needle electrode.
Product CodeGXZ
Regulation Number 882.1350
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
BIO-DETEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TECHNOMED EUROPE
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Material separation 7
Break 3
Lead(s), burn(s) from 3
No Known Device Problem 3
Detachment of device or device component 2
Material integrity issue 1
Mechanical issue 1
Needle, separation 1
Unsealed device packaging 1
Material fragmentation 1
Improper or incorrect procedure or method 1
Total Device Problems 24

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 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 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010

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