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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, absorbable, synthetic, polyglycolic acid
Regulation Description Absorbable poly(glycolide/l-lactide) surgical suture.
Product CodeGAM
Regulation Number 878.4493
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 5
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AUROLAB
  SUBSTANTIALLY EQUIVALENT 1
COAPT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  1
  SUBSTANTIALLY EQUIVALENT 17
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MANI, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MITEK
  SUBSTANTIALLY EQUIVALENT 1
NEAT STITCH LTD.
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SAMYANG CORP.
  SUBSTANTIALLY EQUIVALENT 1
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 7
SUTURES INDIA PVT., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
UNITED STATES SURGICAL
  4
  SUBSTANTIALLY EQUIVALENT 8
VISIONARY MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 1368
Other (for use when an appropriate device code cannot be identified) 641
No code available 498
Failure to Adhere or Bond 300
Reaction 237
Needle, separation 212
No Known Device Problem 133
Bent 89
Detachment of device component 71
Device operates differently than expected 71
Migration of device or device component 65
Absorption 55
Packaging issue 51
Detachment of device or device component 42
Product quality issue 37
Material integrity issue 31
Unknown (for use when the device problem is not known) 27
Tear, rip or hole in device packaging 21
Defective item 20
Device markings issue 18
Degraded 16
Device or device fragments location unknown 15
No Information 15
Component missing 14
Material frayed 14
Battery charger, defective 13
Material fragmentation 11
Material disintegration 11
Knotted 11
Device misassembled during manufacturing or shipping 11
Failure to unwrap 10
Unraveled material 10
Material deformation 10
Manufacturing or shipping issue associated with device 8
Incomplete or missing packaging 8
Device remains implanted 7
Defective component 7
Slippage of device or device component 6
Component falling 6
Patient-device incompatibility 6
Difficult to open or remove packaging material 5
Implant extrusion 5
Tip breakage 5
Nonstandard device or device component 4
Unsealed device packaging 4
Expulsion 4
Device packaging compromised 4
Incompatibility problem 3
Material perforation 3
Rejection 3
Entrapment of device or device component 3
Item contaminated during manufacturing or shipping 3
Torn material 2
Loss of or failure to bond 2
Delivered as unsterile product 2
Sticking 2
Unexpected therapeutic results 2
Material rigid or stiff 2
Device damaged prior to use 2
Out-of-box failure 2
Device Issue 2
Device disinfection or sterilization issue 2
Delamination 1
Incorrect device or component shipped 1
Foreign material present in device 1
Device displays error message 1
Device, removal of (non-implant) 1
Folded 1
Dull 1
Cut in material 1
Split 1
Material separation 1
Difficult to remove 1
Leak 1
Mechanical issue 1
Crack 1
Failure to cycle 1
Unintended ejection 1
Fracture 1
Kinked 1
Mechanical jam 1
Naturally worn 1
Total Device Problems 4282

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 2 1 1 2 1 1 1 2 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Oct-26-2016
2 C P Medical II May-24-2007
3 C P Medical Inc. II Nov-19-2011
4 Coloplast Manufacturing US, LLC II Jun-05-2013
5 Ethicon, Inc. II May-18-2010
6 Ethicon, Inc. II May-12-2009
7 Ethicon, Inc. II Oct-02-2008
8 Mani, Inc. - Kiyohara Facility II Jan-11-2012
9 Silhouette Lift, Inc. II Jul-23-2015
10 Telefelx Medical II Aug-26-2010
11 Teleflex Creek Dr II Jul-17-2007
12 Teleflex Medical II May-07-2014
13 Teleflex Medical II May-01-2014

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