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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLRP
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 5
Occlusion within device 5
Device, or device fragments remain in patient 1
Fitting problem 1
Difficult to advance 1
Crack 1
Elective removal 1
Difficult to insert 1
Loose 1
Total Device Problems 17

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 2 1 5 5 0 0 0 1
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Oct-08-2009
2 B. Braun Medical, Inc. II Nov-01-2016
3 Cardinal Health II Jan-26-2012
4 Cardinal Health II Nov-07-2011
5 Cardinal Health II Oct-31-2011
6 Custom Medical Specialties, Inc. II Sep-07-2012
7 DePuy Spine, Inc. II Dec-27-2010
8 DeRoyal Industries Inc II Apr-12-2012
9 DeRoyal Industries Inc II Feb-06-2012
10 DeRoyal Processing Center II Feb-13-2012
11 Deroyal Industries, Inc. Lafollette II Jul-28-2011
12 Deroyal Industries, Inc. Lafollette II May-20-2011
13 Ethicon Endo-Surgery Inc II Feb-15-2011
14 Tri-State Hospital Supply Corporation II Apr-30-2009
15 Tri-State Hospital Supply Corporation III Feb-23-2008

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