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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, suturing, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeGAB
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ANCHOR PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Tip breakage 9
Break 8
Device, or device fragments remain in patient 2
Unknown (for use when the device problem is not known) 1
Detachment of device or device component 1
Needle, separation 1
Shaft break 1
Device Issue 1
Total Device Problems 24

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 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-06-2011

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