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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, polyamide
Regulation Description Nonabsorbable polyamide surgical suture.
Product CodeGAR
Regulation Number 878.5020
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  1
ARTIMPLANT AB
  SUBSTANTIALLY EQUIVALENT 2
AUROLAB
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
FSSB CHIRURGISCHE NADELN GMBH
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
MANI, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUILL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 4
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNILENE S.A.C.
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  1
  SUBSTANTIALLY EQUIVALENT 2
VISIONARY MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 122
No code available 37
Failure to Adhere or Bond 33
Other (for use when an appropriate device code cannot be identified) 23
Bent 15
Detachment of device component 12
Reaction 7
Device misassembled during manufacturing or shipping 6
Device markings issue 5
Packaging issue 5
Needle, separation 4
Device operates differently than expected 4
Tear, rip or hole in device packaging 4
Product quality issue 4
Unknown (for use when the device problem is not known) 4
Material frayed 3
Knotted 3
Detachment of device or device component 3
Stretched 3
Nonstandard device or device component 3
Dull 2
Manufacturing or shipping issue associated with device 2
Battery charger, defective 2
Size incorrect for patient 2
Component incompatible 2
Unsealed device packaging 2
No Known Device Problem 2
Defective component 2
Occlusion within device 1
Misassembled 1
Delivered as unsterile product 1
Loss of or failure to bond 1
Component missing 1
Incomplete or missing packaging 1
Item contaminated during manufacturing or shipping 1
Material rupture 1
Device damaged prior to use 1
Kinked 1
Split 1
Crack 1
Implant extrusion 1
Total Device Problems 329

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

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Jul-09-2014
2 C P Medical Inc. II Sep-09-2011
3 Riverpoint Medical, LLC II Sep-08-2016
4 Surgical Specialties Corp III Oct-02-2008
5 Teleflex Medical II May-07-2014

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