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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable, synthetic, polyethylene
Regulation Description Nonabsorbable poly(ethylene terephthalate) surgical suture.
Product CodeGAT
Regulation Number 878.5000
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ANULEX TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 4
ARC MEDICAL
  1
ARTHREX, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 11
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  1
  SUBSTANTIALLY EQUIVALENT 3
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MANI, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 2
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 3
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SENTREHEART INC.
  SUBSTANTIALLY EQUIVALENT 3
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
SORIN
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  1
  SUBSTANTIALLY EQUIVALENT 2
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 4
XIROS PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 131
No code available 53
Deployment issue 47
Failure to deploy 38
Device operates differently than expected 25
Tear, rip or hole in device packaging 22
Detachment of device component 22
Premature deployment 22
Detachment of device or device component 20
Other (for use when an appropriate device code cannot be identified) 19
Dislodged or dislocated 14
Component falling 12
Device Issue 11
No Known Device Problem 11
Failure to Adhere or Bond 10
Device, or device fragments remain in patient 8
Misfire 6
Failure to fire 6
Improper or incorrect procedure or method 5
Unknown (for use when the device problem is not known) 5
Component missing 5
Sticking 5
Bent 5
Loose or intermittent connection 4
Migration of device or device component 4
Material integrity issue 4
Difficult to open or close 4
No Information 4
Packaging issue 3
Defective item 3
Needle, separation 3
Difficult to deploy 3
Battery charger, defective 3
Difficult to remove 3
Self-activation or keying 3
Material frayed 3
Source, detachment from 2
Retraction problem 2
Suture line separation 2
Incomplete or missing packaging 2
Material fragmentation 2
Design/structure problem 1
Material disintegration 1
Material erosion 1
Flaked 1
Loss of or failure to bond 1
Component incompatible 1
Component(s), broken 1
Material perforation 1
Device inoperable 1
Unraveled material 1
Unstable 1
Product quality issue 1
Slippage of device or device component 1
Split 1
Failure to form staple 1
Cut in material 1
Structural problem 1
Mechanical jam 1
Material deformation 1
Device packaging compromised 1
Positioning Issue 1
Total Device Problems 577

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 1 0 0 1 0 1 0 3 1 0 0
Class III 0 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 Innovatech Medical Resources L.P. II Jan-11-2012
3 Peters Surgical II Sep-22-2014
4 Smith & Nephew, Inc. II Jun-22-2015
5 Smith & Nephew, Inc. Endoscopy Division II Nov-18-2010
6 Teleflex Medical II May-07-2014
7 Teleflex Medical II Mar-26-2014

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