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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, surgical instrument, ac-powered
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGEY
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device inoperable 277
Device operates differently than expected 100
Mechanical jam 41
Failure to power-up 30
Sticking 29
Loss of power 21
Break 19
Loose or intermittent connection 18
Noise, Audible 15
Overheating of device or device component 12
Failure to charge 11
Battery issue 11
Temperature issue 10
Fluid leak 10
Power source issue 10
Mechanical issue 9
Leak 9
Device stops intermittently 9
Defective item 8
Device displays error message 7
Defective component 7
Blockage within device or device component 7
Component falling 6
Material separation 6
Connection issue 6
Failure to shut off 6
Naturally worn 5
Slippage of device or device component 5
Detachment of device or device component 4
Detachment of device component 4
Power Conditioning Issue 4
Physical resistance 4
Device remains activated 3
Air leak 3
Bent 3
Smoking 3
Component missing 3
Vibration 3
Fitting problem 3
Self-activation or keying 2
Device contamination with blood or blood product 2
Failure to calibrate 2
Output below specifications 2
Positioning Issue 2
Torn material 2
Fracture 2
Component incompatible 2
Crack 2
Unintended ejection 2
Melted 1
Moisture damage 1
Device emits odor 1
Retraction problem 1
Material rupture 1
Difficult to position 1
Application interface becomes non-functional or program exits abnormally 1
Decoupling 1
Decrease in suction 1
Unintended energization 1
Failure to discharge 1
Disconnection 1
Hole in material 1
Difficult to insert 1
Device clogged 1
Unintended movement 1
Misassembled by Users 1
Not Applicable 1
Device handling issue 1
Moisture or humidity problem 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Difficult to open or close 1
Difficult or delayed activation 1
Improper or incorrect procedure or method 1
Inappropriate shock 1
Unraveled material 1
Pressure issue 1
Total Device Problems 789

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 3 1 1
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. dba ConMed Linvatec III Mar-06-2013
2 Linvatec Corp. dba ConMed Linvatec II Jul-17-2010
3 MEDICAMAT S.A. II Mar-04-2014
4 Nico Corp. II Jun-21-2016
5 Nico Corp. II Sep-15-2015
6 Synthes U S A II Sep-21-2008
7 The Anspach Effort, Inc. II Jun-25-2014
8 The Anspach Effort, Inc. II Jan-06-2014

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