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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, absorbable, natural
Regulation Description Absorbable surgical gut suture.
Product CodeGAL
Regulation Number 878.4830
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SUTURTEK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
  3

Device Problems
Break 144
Other (for use when an appropriate device code cannot be identified) 37
No code available 18
Material integrity issue 16
Material frayed 13
Reaction 11
Device operates differently than expected 10
Manufacturing or shipping issue associated with device 9
Packaging issue 8
Implant extrusion 6
No Known Device Problem 5
Fluid leak 5
Leak 4
Crack 4
Defective item 4
Detachment of device or device component 3
Knotted 3
Detachment of device component 3
Absorption 3
Failure to Adhere or Bond 3
Bent 2
Needle, separation 2
Product quality issue 2
Device Issue 2
Material deformation 2
Material twisted 2
Torn material 2
Item contaminated during manufacturing or shipping 1
Incorrect or inadequate test results 1
Device markings issue 1
Unsealed device packaging 1
Material separation 1
Defective component 1
Degraded 1
Material disintegration 1
Total Device Problems 331

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 Ethicon, Inc. II Jun-25-2015

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