• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 278
Device operates differently than expected 104
Mechanical jam 65
Failure to power-up 33
Sticking 29
Unintended system motion 25
Fail-safe mechanism issue 24
Overheating of device or device component 22
Break 22
Loss of power 21
Loose or intermittent connection 18
Noise, Audible 17
Fluid leak 15
Failure to charge 11
Battery issue 11
Power source issue 10
Temperature issue 10
Mechanical issue 9
Leak 9
Device stops intermittently 9
Defective item 8
Component falling 7
Blockage within device or device component 7
Material separation 7
Defective component 7
Device displays error message 7
Connection issue 6
Failure to shut off 6
Slippage of device or device component 5
Naturally worn 5
Detachment of device component 5
Air leak 4
Detachment of device or device component 4
Difficult to position 4
Component missing 4
Power Conditioning Issue 4
Physical resistance 4
Bent 3
Vibration 3
Failure to Adhere or Bond 3
Smoking 3
Device remains activated 3
Component incompatible 3
Fitting problem 3
Torn material 2
Crack 2
Positioning Issue 2
Difficult to insert 2
Self-activation or keying 2
Output below specifications 2
Unintended ejection 2
Failure to calibrate 2
Device contamination with blood or blood product 2
Fracture 2
Application interface becomes non-functional or program exits abnormally 1
Decoupling 1
Material integrity issue 1
Inappropriate shock 1
Improper or incorrect procedure or method 1
Structural problem 1
Not Applicable 1
Difficult to open or close 1
Retraction problem 1
Melted 1
Circuit Failure 1
Unraveled material 1
Unintended energization 1
Moisture damage 1
Moisture or humidity problem 1
Disconnection 1
Material rupture 1
Difficult or delayed activation 1
Manufacturing or shipping issue associated with device 1
Decrease in suction 1
Failure to discharge 1
Material deformation 1
Unintended movement 1
Pressure issue 1
Fail-safe design failure 1
Device emits odor 1
Device clogged 1
Device or device component damaged by another device 1
Hole in material 1
Misassembled by Users 1
Device handling issue 1
Total Device Problems 908

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

-
-