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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 153
Other (for use when an appropriate device code cannot be identified) 37
No code available 24
Material integrity issue 16
Material frayed 14
Reaction 11
Device operates differently than expected 10
Manufacturing or shipping issue associated with device 9
Packaging issue 8
Implant extrusion 6
Detachment of device component 6
Fluid leak 5
No Known Device Problem 5
Detachment of device or device component 5
Defective item 4
Failure to Adhere or Bond 4
Crack 4
Leak 4
Knotted 3
Bent 3
Absorption 3
Needle, separation 2
Product quality issue 2
Torn material 2
Material deformation 2
Material twisted 2
Device Issue 2
Incorrect or inadequate test results 1
Defective component 1
Device markings issue 1
Item contaminated during manufacturing or shipping 1
Material separation 1
Unsealed device packaging 1
Degraded 1
Material disintegration 1
Total Device Problems 354

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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