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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable
Regulation Description Stainless steel suture.
Product CodeGAO
Regulation Number 878.4495
Device Class 2


Premarket Reviews
ManufacturerDecision
A&E
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 56
Break 31
Reaction 9
Unknown (for use when the device problem is not known) 6
Detachment of device component 5
Unsealed device packaging 2
Component(s), broken 1
Material erosion 1
Explanted 1
Fracture 1
Material fragmentation 1
Needle, separation 1
Split 1
Sharp/jagged/rough/etched/scratched 1
No Known Device Problem 1
No code available 1
Total Device Problems 119

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

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015

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