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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blade, saw, general & plastic surgery, surgical
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFA
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
J-PAC, LLC.
  SUBSTANTIALLY EQUIVALENT 1
SPIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 100
Break 95
Bent 50
Device inoperable 44
Mechanical issue 21
Ambient noise issue 15
Vibration 13
Fracture 13
Foreign material present in device 9
Material Protrusion 9
Noise, Audible 9
Slippage of device or device component 8
Crack 8
Detachment of device component 7
Overheating of device or device component 7
Failure to power-up 7
Component missing 7
Material deformation 7
Connection issue 7
Corrosion 6
Loose or intermittent connection 5
Shaft break 5
Component falling 5
Component(s), broken 5
Material fragmentation 5
Handpiece detachment 5
Hole in material 4
Blockage within device or device component 4
Mechanical jam 4
Loss of power 4
Metal shedding debris 4
Temperature issue 4
Torn material 4
Dull 3
Cut in material 3
Failure to align 3
Naturally worn 3
Packaging issue 3
Material integrity issue 3
Material twisted 3
Self-activation or keying 3
Material separation 3
Failure to service 2
Peeled 2
Difficult to position 2
Contamination during use 2
Detachment of device or device component 2
Device or device fragments location unknown 2
Split 2
Fitting problem 2
Failure to cut 2
Sticking 2
Device stops intermittently 2
Stretched 1
Transducer overheating 1
Improper or incorrect procedure or method 1
Unstable 1
Use of Device Issue 1
Defective item 1
Failure to disconnect 1
Malposition of device 1
Incompatibility problem 1
Maintenance does not comply to manufacturers recommendations 1
Positioning Issue 1
No Known Device Problem 1
Accessory incompatible 1
Failure to Adhere or Bond 1
Leak 1
Disassembly 1
Disconnection 1
Device expiration issue 1
Unsealed device packaging 1
Delivered as unsterile product 1
Output energy incorrect 1
Size incorrect for patient 1
Device remains activated 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Retraction problem 1
Device Difficult to maintain 1
Total Device Problems 576

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 2 1 1 2 2 2 0 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Sep-29-2008
2 Linvatec Corp. dba ConMed Linvatec II Feb-10-2012
3 Linvatec Corp. dba ConMed Linvatec II Sep-25-2010
4 Sterilmed Inc II Jan-13-2009
5 Stryker Endoscopy II Jun-25-2012
6 Stryker Instruments Division of Stryker Corporation II Jul-12-2011
7 Stryker Sustainability Solutions II Nov-06-2015
8 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
9 Synvasive Technology Inc II Dec-22-2015
10 Synvasive Technology Inc II Apr-15-2013
11 Terumo Cardiovascular Systems Corporation II Jan-26-2011
12 Terumo Cardiovascular Systems Corporation II Dec-02-2008

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