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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device saw, powered, and accessories
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHAB
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Metal shedding debris 74
Overheating of device or device component 44
Break 12
Spark 10
No Known Device Problem 10
Smoking 7
Device operates differently than expected 6
Foreign material present in device 6
Device inoperable 5
Electrical issue 5
Temperature issue 4
Noise, Audible 4
Device Issue 3
Self-activation or keying 3
Device remains activated 2
Material fragmentation 2
Burn of device or device component 2
Failure to shut off 2
Cut in material 1
Device displays error message 1
Fitting problem 1
Mechanical jam 1
Power source issue 1
Detachment of device component 1
Unintended energization 1
Fluid leak 1
Battery charger, defective 1
Blockage within device or device component 1
Leak 1
Loose or intermittent connection 1
Melted 1
Loss of power 1
Total Device Problems 215

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

Recalls
Manufacturer Recall Class Date Posted
1 Ascent Healthcare Solutions, Inc. II Sep-19-2008
2 Smith & Nephew, Inc. Endoscopy Division II Jul-01-2011
3 Zimmer Surgical Inc II Oct-31-2014
4 Zimmer, Inc. II Dec-21-2015

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