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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drill, bone, powered
Regulation Description Bone cutting instrument and accessories.
Product CodeDZI
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 3
STRAUMANN
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 19
Device stops intermittently 3
Overheating of device or device component 2
Burn of device or device component 1
Fitting problem 1
Component missing 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Device operates differently than expected 1
Inadequate user interface 1
Total Device Problems 31

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 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 Nov-16-2009

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