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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, polypropylene
Regulation Description Nonabsorbable polypropylene surgical suture.
Product CodeGAW
Regulation Number 878.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ANGIOTECH
  SUBSTANTIALLY EQUIVALENT 2
ARC MEDICAL
  1
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NEOTRACT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
QUILL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 2
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUTURA, INC.
  SUBSTANTIALLY EQUIVALENT 4
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
  2
VISIONARY MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 468
Failure to Adhere or Bond 295
Other (for use when an appropriate device code cannot be identified) 50
No code available 44
Material frayed 33
Material integrity issue 32
Detachment of device or device component 32
Detachment of device component 25
Needle, separation 25
Battery charger, defective 19
Bent 19
Reaction 16
Device operates differently than expected 15
No Known Device Problem 14
Kinked 10
Product quality issue 8
Knotted 7
Mechanical issue 5
Packaging issue 5
Material deformation 5
Sharp/jagged/rough/etched/scratched 5
Split 5
Size incorrect for patient 4
Coiled 3
Crack 3
Dull 3
No Information 3
Device misassembled during manufacturing or shipping 2
Device or device fragments location unknown 2
Device Issue 2
Tear, rip or hole in device packaging 2
Unraveled material 2
Component missing 2
Incomplete or missing packaging 2
Leak 2
Device remains implanted 2
Material separation 2
Unsealed device packaging 2
Suture line disruption 2
Unknown (for use when the device problem is not known) 2
Device damaged prior to use 1
Defective component 1
Tip breakage 1
Slippage of device or device component 1
Device Difficult to Setup or Prepare 1
Migration of device or device component 1
Misassembled 1
Loose or intermittent connection 1
Device maintenance issue 1
Difficult to insert 1
Burst 1
Difficult to deploy 1
Material disintegration 1
Elective removal 1
Fracture 1
Loss of or failure to bond 1
Solder joint failure 1
Implant extrusion 1
Endarterectomy suture breakage 1
Device markings issue 1
Difficult to open or close 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Incorrect device or component shipped 1
Item contaminated during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 1205

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 1 0 0 0 0 0 0 0 0 1
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 SSC- Surgical Specialties Corporation II Jun-21-2016

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