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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 182
Other (for use when an appropriate device code cannot be identified) 37
No code available 28
Material frayed 18
Material integrity issue 16
Reaction 11
Detachment of device component 10
Device operates differently than expected 10
Manufacturing or shipping issue associated with device 9
Packaging issue 9
Failure to Adhere or Bond 7
Implant extrusion 6
Detachment of device or device component 5
Fluid leak 5
Leak 5
No Known Device Problem 5
Knotted 4
Bent 4
Crack 4
Defective item 4
Material twisted 3
Incorrect device or component shipped 3
Absorption 3
Needle, separation 2
Unsealed device packaging 2
Product quality issue 2
Material deformation 2
Device markings issue 2
Device Issue 2
Torn material 2
Incorrect or inadequate test results 1
Misfire 1
Defective component 1
Component missing 1
Device misassembled during manufacturing or shipping 1
Item contaminated during manufacturing or shipping 1
Difficult to open or close 1
Material separation 1
Unraveled material 1
Migration of device or device component 1
Degraded 1
Material disintegration 1
Entrapment of device or device component 1
Total Device Problems 415

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 0 0 0 1 0 0
Class III 0 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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