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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device expander, surgical, skin graft
Regulation Description Manual surgical instrument for general use.
Product CodeFZW
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to cut 69
Bent 40
Device operates differently than expected 14
Item contaminated during manufacturing or shipping 6
Sticking 5
Device inoperable 4
Break 3
Calibration issue 3
Foreign material present in device 3
Failure to separate 2
Material deformation 2
Mechanical jam 2
Power source issue 2
Detachment of device component 2
Delivered as unsterile product 2
Loss of power 1
Difficult to remove 1
Failure to service 1
Use of Device Issue 1
Component missing 1
Dull 1
Corrosion 1
Material discolored 1
Material disintegration 1
Loose or intermittent connection 1
Mechanical issue 1
No Information 1
Device stops intermittently 1
Improper device output 1
Total Device Problems 173

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

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. dba ConMed Linvatec II Sep-28-2010
2 Molnlycke Health Care, Inc II May-03-2017
3 Zimmer Inc. II Jul-30-2008

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