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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, surgical instrument, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeKDD
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT - KIT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
Delivered as unsterile product 27
Material integrity issue 7
No code available 6
Break 4
Leak 4
Product quality issue 3
Device operates differently than expected 3
Tear, rip or hole in device packaging 3
Item contaminated during manufacturing or shipping 3
Manufacturing or shipping issue associated with device 3
Air leak 2
No Known Device Problem 2
Mechanical issue 2
Fluid leak 2
Material frayed 2
Degraded 2
Failure to deploy 1
Flaked 1
Crack 1
Difficult to insert 1
Material separation 1
Improper or incorrect procedure or method 1
Defective component 1
Device Issue 1
Occlusion within device 1
Unsealed device packaging 1
Difficult to position 1
Device Difficult to Setup or Prepare 1
Not Applicable 1
Foreign material present in device 1
Incorrect device or component shipped 1
Mechanical jam 1
Material deformation 1
Material Distortion 1
Dull 1
Strikethrough 1
Defective item 1
Deployment issue 1
Total Device Problems 97

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 2 3 3 0 1 0 0 0 2 0
Class III 0 0 0 0 0 1 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Jul-19-2011
2 Biomet Microfixation, Inc. II Dec-15-2009
3 Covidien LLC III May-11-2013
4 DeRoyal Industries Inc II Nov-07-2008
5 DeRoyal Lafollette II Aug-29-2007
6 Deroyal Industries, Inc. Lafollette III Apr-17-2012
7 K Tek II Sep-25-2007
8 Merit Medical Systems, Inc. II Nov-23-2009
9 Merit Medical Systems, Inc. II Sep-19-2008
10 Merit Medical Systems, Inc. II Sep-11-2008
11 Tri-State Hospital Supply Corporation II Apr-30-2009
12 Utah Medical Products, Inc II Nov-06-2015
13 Windstone Medical Packaging, Inc. II Dec-04-2015

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