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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 1185
Other (for use when an appropriate device code cannot be identified) 641
No code available 256
Reaction 236
Needle, separation 212
Failure to Adhere or Bond 208
No Known Device Problem 106
Device operates differently than expected 60
Bent 59
Absorption 55
Packaging issue 45
Migration of device or device component 44
Detachment of device component 35
Material integrity issue 29
Detachment of device or device component 28
Unknown (for use when the device problem is not known) 27
Defective item 20
No Information 15
Material frayed 14
Product quality issue 14
Battery charger, defective 13
Device or device fragments location unknown 13
Device markings issue 12
Failure to unwrap 10
Material deformation 10
Degraded 10
Material fragmentation 8
Manufacturing or shipping issue associated with device 8
Tear, rip or hole in device packaging 7
Defective component 7
Material disintegration 7
Knotted 7
Device remains implanted 7
Patient-device incompatibility 6
Device misassembled during manufacturing or shipping 6
Difficult to open or remove packaging material 5
Implant extrusion 5
Component missing 5
Incomplete or missing packaging 5
Tip breakage 5
Unraveled material 4
Slippage of device or device component 4
Nonstandard device or device component 4
Device packaging compromised 4
Incompatibility problem 3
Item contaminated during manufacturing or shipping 3
Material perforation 3
Device damaged prior to use 2
Device Issue 2
Expulsion 2
Delivered as unsterile product 2
Rejection 2
Unexpected therapeutic results 2
Loss of or failure to bond 2
Component falling 1
Failure to conduct 1
Failure to cycle 1
Material erosion 1
Burst 1
Kinked 1
Difficult to remove 1
Material rigid or stiff 1
Material separation 1
Mechanical issue 1
Incorrect device or component shipped 1
Mechanical jam 1
Naturally worn 1
Torn material 1
Out-of-box failure 1
Delamination 1
Cut in material 1
Device displays error message 1
Device, removal of (non-implant) 1
Folded 1
Total Device Problems 3504

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 0
Class III 0 0 0 0 0 0 0 0 0 0

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

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