• 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 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 84
Bent 49
Device inoperable 44
Mechanical issue 19
Ambient noise issue 15
Fracture 12
Foreign material present in device 9
Material Protrusion 9
Vibration 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
Component missing 7
Connection issue 7
Corrosion 6
Loose or intermittent connection 5
Component falling 5
Component(s), broken 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
Material fragmentation 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
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 544

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 2 1 1 2 2 2 0 2 0
Class III 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

-
-