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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 90
Bent 49
Device inoperable 44
Mechanical issue 19
Ambient noise issue 15
Fracture 12
Vibration 11
Foreign material present in device 9
Material Protrusion 9
Noise, Audible 9
Slippage of device or device component 8
Overheating of device or device component 7
Failure to power-up 7
Crack 7
Detachment of device component 7
Connection issue 7
Component missing 7
Corrosion 6
Loose or intermittent connection 5
Component falling 5
Component(s), broken 5
Material fragmentation 5
Handpiece detachment 5
Shaft break 5
Loss of power 4
Metal shedding debris 4
Temperature issue 4
Torn material 4
Mechanical jam 4
Hole in material 4
Blockage within device or device component 4
Self-activation or keying 3
Material separation 3
Sticking 3
Naturally worn 3
Material twisted 3
Material integrity issue 3
Cut in material 3
Failure to align 3
Split 2
Failure to cut 2
Device or device fragments location unknown 2
Fitting problem 2
No Known Device Problem 2
Packaging issue 2
Device stops intermittently 2
Failure to service 2
Peeled 2
Difficult to position 2
Contamination during use 2
Accessory incompatible 1
Failure to Adhere or Bond 1
Leak 1
Disassembly 1
Disconnection 1
Device expiration issue 1
Stretched 1
Transducer overheating 1
Delivered as unsterile product 1
Output energy incorrect 1
Device remains activated 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Retraction problem 1
Positioning Issue 1
Device Difficult to maintain 1
Detachment of device or device component 1
Incompatibility problem 1
Maintenance does not comply to manufacturers recommendations 1
Material deformation 1
Malposition of device 1
Defective item 1
Failure to disconnect 1
Improper or incorrect procedure or method 1
Dull 1
Unstable 1
Use of Device Issue 1
Total Device Problems 554

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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