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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
Device operates differently than expected 37
Device inoperable 7
Detachment of device component 4
Flaked 4
Failure to cut 4
Unknown (for use when the device problem is not known) 3
Break 3
Mechanical issue 3
Failure to power-up 3
Performance 2
Sticking 2
Device Issue 2
Malfunction 2
Defective item 2
Calibration issue 2
Material integrity issue 2
No Known Device Problem 2
Power source issue 1
No Information 1
Mechanics altered 1
Electronic property issue 1
Failure to auto stop 1
Foreign material present in device 1
Installation-related problem 1
Detachment of device or device component 1
Defective component 1
Failure to Adhere or Bond 1
Use of Device Issue 1
Fitting problem 1
Loss of power 1
User used incorrect product for intended use 1
Retraction problem 1
Calibration error 1
Leak 1
Loose or intermittent connection 1
Use of Incorrect Control Settings 1
Material erosion 1
Fail-safe design failure 1
Total Device Problems 105

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 0 0 0 1 0 1 1 1 0
Class III 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 Jun-05-2013

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