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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dermatome
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFD
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PADGETT INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to cut 135
Device operates differently than expected 122
Failure to power-up 12
Device inoperable 10
Calibration issue 10
Item contaminated during manufacturing or shipping 10
Power source issue 7
Incorrect measurement 7
Flaked 6
Loss of power 6
Mechanical issue 5
Break 4
Detachment of device component 4
No Known Device Problem 4
No code available 4
Noise, Audible 3
Failure to obtain samples 3
Air leak 3
Sticking 3
Device stops intermittently 3
Device Issue 3
Unknown (for use when the device problem is not known) 3
Device damaged prior to use 2
Malfunction 2
Use of Device Issue 2
Performance 2
Calibration error 2
Delivered as unsterile product 2
Fluid leak 2
Leak 2
Fitting problem 2
Defective item 2
Foreign material present in device 2
Improper device output 2
Material integrity issue 2
No Information 2
Mechanical jam 1
Mechanics altered 1
Installation-related problem 1
Misassembled by Users 1
Connection issue 1
Detachment of device or device component 1
Electronic property issue 1
Failure to auto stop 1
Loose or intermittent connection 1
Imprecision 1
Overheating of device or device component 1
Misassembled 1
Device Cleaning Issue 1
Failure to Adhere or Bond 1
Blockage within device or device component 1
Use of Incorrect Control Settings 1
Electrical issue 1
Material erosion 1
Fail-safe design failure 1
User used incorrect product for intended use 1
Product quality issue 1
Difficult to remove 1
Retraction problem 1
Vibration 1
Failure to calibrate 1
Defective component 1
Component missing 1
Total Device Problems 422

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

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II May-20-2011
2 KCI USA, INC. II Jan-07-2015
3 KCI USA, Inc. II Sep-29-2014
4 Zimmer Surgical Inc II Nov-05-2016
5 Zimmer Surgical Inc II Aug-04-2016
6 Zimmer Surgical Inc II Jun-05-2013

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