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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, manual, surgical, general use
Regulation Description Manual surgical instrument for general use.
Product CodeMDM
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN SAFETY
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
DENVER BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Peeled 25
Other (for use when an appropriate device code cannot be identified) 18
Break 18
Fracture 10
Device, or device fragments remain in patient 7
Difficult to remove 7
Tip breakage 7
Replace 5
Detachment of device component 3
Material frayed 2
Slippage of device or device component 2
Tears, rips, holes in device, device material 2
Unknown (for use when the device problem is not known) 2
Device damaged prior to use 2
Loose 2
Wire(s), breakage of 2
Malfunction 1
Failure to advance 1
Labeling, missing 1
Split 1
Physical resistance 1
Sharp/jagged/rough/etched/scratched 1
Device, removal of (non-implant) 1
Detachment of device or device component 1
Improper or incorrect procedure or method 1
Defective component 1
Difficult to insert 1
Kinked 1
Failure to deploy 1
Displacement 1
Total Device Problems 128

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 2 2 1 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Aug-16-2010
2 Merit Medical Systems, Inc. II Dec-14-2009
3 Stryker Instruments Division of Stryker Corporation II Jul-06-2011
4 Stryker Spine II Aug-09-2012
5 Stryker Spine II Jul-08-2010
6 Stryker Spine II Feb-03-2009

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