• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
Crack 1
Elective removal 1
Difficult to insert 1
Loose 1
Total Device Problems 16

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 0
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 Cardinal Health II Jan-26-2012
3 Cardinal Health II Nov-07-2011
4 Cardinal Health II Oct-31-2011
5 Custom Medical Specialties, Inc. II Sep-07-2012
6 DePuy Spine, Inc. II Dec-27-2010
7 DeRoyal Industries Inc II Apr-12-2012
8 DeRoyal Industries Inc II Feb-06-2012
9 DeRoyal Processing Center II Feb-13-2012
10 Deroyal Industries, Inc. Lafollette II Jul-28-2011
11 Deroyal Industries, Inc. Lafollette II May-20-2011
12 Ethicon Endo-Surgery Inc II Feb-15-2011
13 Tri-State Hospital Supply Corporation II Apr-30-2009
14 Tri-State Hospital Supply Corporation III Feb-23-2008

-
-