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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 1314
Other (for use when an appropriate device code cannot be identified) 641
No code available 454
Failure to Adhere or Bond 271
Reaction 236
Needle, separation 212
No Known Device Problem 121
Bent 88
Device operates differently than expected 66
Migration of device or device component 62
Absorption 55
Detachment of device component 52
Packaging issue 51
Detachment of device or device component 38
Material integrity issue 31
Unknown (for use when the device problem is not known) 27
Product quality issue 23
Defective item 21
Tear, rip or hole in device packaging 17
Device markings issue 16
Degraded 15
No Information 15
Material frayed 14
Device or device fragments location unknown 14
Battery charger, defective 13
Knotted 11
Material disintegration 10
Failure to unwrap 10
Component missing 10
Material deformation 10
Unraveled material 9
Material fragmentation 9
Device misassembled during manufacturing or shipping 8
Incomplete or missing packaging 8
Manufacturing or shipping issue associated with device 8
Defective component 7
Device remains implanted 7
Slippage of device or device component 6
Patient-device incompatibility 6
Difficult to open or remove packaging material 5
Implant extrusion 5
Tip breakage 5
Expulsion 4
Device packaging compromised 4
Nonstandard device or device component 4
Material perforation 3
Item contaminated during manufacturing or shipping 3
Incompatibility problem 3
Torn material 2
Device damaged prior to use 2
Sticking 2
Unexpected therapeutic results 2
Out-of-box failure 2
Device Issue 2
Delivered as unsterile product 2
Unsealed device packaging 2
Material rigid or stiff 2
Rejection 2
Loss of or failure to bond 2
Component falling 2
Failure to conduct 1
Crack 1
Failure to cycle 1
Burst 1
Material erosion 1
Unintended ejection 1
Fracture 1
Material separation 1
Difficult to remove 1
Leak 1
Mechanical issue 1
Kinked 1
Delamination 1
Device displays error message 1
Device, removal of (non-implant) 1
Folded 1
Foreign material present in device 1
Dull 1
Cut in material 1
Split 1
Mechanical jam 1
Naturally worn 1
Incorrect device or component shipped 1
Total Device Problems 4069

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