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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 280
Unintended system motion 158
Fail-safe mechanism issue 151
Mechanical jam 140
Device operates differently than expected 112
Overheating of device or device component 38
Failure to power-up 34
Fluid leak 32
Sticking 29
Mechanical issue 23
Break 22
Loss of power 22
Noise, Audible 20
Loose or intermittent connection 18
Device stops intermittently 13
Leak 13
Detachment of device component 12
Battery issue 11
Failure to charge 10
Power source issue 10
Temperature issue 10
Defective item 8
Material separation 7
Vibration 7
Defective component 7
Blockage within device or device component 7
Component falling 7
Difficult to position 6
Device displays error message 6
Connection issue 6
Failure to shut off 6
Naturally worn 5
Slippage of device or device component 5
Component missing 4
Detachment of device or device component 4
Power Conditioning Issue 4
Difficult to insert 4
Air leak 4
Physical resistance 4
Failure to Adhere or Bond 3
Bent 3
Component incompatible 3
Fracture 3
Device remains activated 3
Fitting problem 3
Output below specifications 3
Smoking 3
Device contamination with blood or blood product 2
Failure to calibrate 2
Positioning Issue 2
Self-activation or keying 2
Device or device component damaged by another device 2
Crack 2
Unintended ejection 2
Torn material 2
Unintended movement 1
Misassembled by Users 1
Not Applicable 1
Device handling issue 1
Pressure issue 1
Circuit Failure 1
Device clogged 1
Application interface becomes non-functional or program exits abnormally 1
Decoupling 1
Decrease in suction 1
Unintended energization 1
Disassembly 1
Failure to discharge 1
Disconnection 1
Fail-safe design failure 1
Retraction problem 1
Material rupture 1
No device output 1
Hole in material 1
Melted 1
Moisture damage 1
Device emits odor 1
Difficult to open or close 1
Moisture or humidity problem 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Material integrity issue 1
Structural problem 1
Failure to disconnect 1
Difficult or delayed activation 1
Improper or incorrect procedure or method 1
Unraveled material 1
Inappropriate shock 1
Total Device Problems 1332

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 1 0 0 0 3 1 1 0
Class III 0 0 0 0 0 0 1 0 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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