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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
Delamination 85
Break 37
No code available 10
Material fragmentation 6
Failure to align 5
No Known Device Problem 4
Flaked 4
Device operates differently than expected 3
Peeled 3
Use of Device Issue 2
Component missing 2
Bent 2
Component incompatible 2
Crack 2
Defective item 2
Detachment of device or device component 2
Device markings issue 1
Device packaging compromised 1
Difficult to advance 1
Electro-magnetic interference (EMI) 1
Material erosion 1
Failure to Adhere or Bond 1
Loose or intermittent connection 1
Overheating of device or device component 1
Dull 1
Difficult or delayed activation 1
Fitting problem 1
Material separation 1
Sticking 1
Total Device Problems 184

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 0 0 0 0 1 5 1 3 2 0
Class III 0 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 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
4 SpineFrontier, Inc. II Aug-13-2013
5 SpineFrontier, Inc. II Aug-08-2013
6 SpineFrontier, Inc. II Aug-01-2013
7 SpineFrontier, Inc. II Jul-05-2013
8 Stryker Craniomaxillofacial Division II Oct-08-2015
9 Synthes (USA) Products LLC II Dec-21-2016
10 Synthes (USA) Products LLC II Aug-20-2015
11 Zimmer, Inc. II Oct-06-2015
12 Zimmer, Inc. II Aug-20-2014

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