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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device driver, wire, and bone drill, manual
Regulation Description Bone cutting instrument and accessories.
Product CodeDZJ
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Unintended energization 11
Device displays error message 3
Unintended movement 3
Break 2
Device operates differently than expected 2
Leak 2
Unintended system motion 2
Overheating of device or device component 2
Reuse 1
Electrical issue 1
Fluid leak 1
Inadequate instructions for healthcare professional 1
Incorrect device or component shipped 1
Total Device Problems 32

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 0 1 0 1 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 Oct-28-2013
2 Stryker Instruments Div. of Stryker Corporation II Nov-16-2011

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