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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HU-FRIEDY
  SUBSTANTIALLY EQUIVALENT 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 5
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RILEY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 18
Failure to align 5
No code available 5
No Known Device Problem 4
Delamination 4
Material fragmentation 4
Component incompatible 2
Crack 2
Use of Device Issue 2
Device operates differently than expected 2
Difficult to advance 1
Fitting problem 1
Component missing 1
Dull 1
Detachment of device or device component 1
Device markings issue 1
Difficult or delayed activation 1
Defective item 1
Material erosion 1
Peeled 1
Sticking 1
Failure to Adhere or Bond 1
Bent 1
Total Device Problems 61

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 0 1 5 1 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Mar-28-2013
2 Customed, Inc II Mar-21-2012
3 SpineFrontier, Inc. II Aug-13-2013
4 SpineFrontier, Inc. II Aug-08-2013
5 SpineFrontier, Inc. II Aug-01-2013
6 SpineFrontier, Inc. II Jul-05-2013
7 Stryker Craniomaxillofacial Division II Oct-08-2015
8 Synthes (USA) Products LLC II Aug-20-2015
9 Zimmer, Inc. II Oct-06-2015
10 Zimmer, Inc. II Aug-20-2014

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