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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, surgical, absorbable, polydioxanone
Regulation Description Absorbable polydioxanone surgical suture.
Product CodeNEW
Regulation Number 878.4840
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ANGIOTECH
  SUBSTANTIALLY EQUIVALENT 2
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
  SUBSTANTIALLY EQUIVALENT 3
FOOSIN MEDICAL SUPPLIES INC.
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
QUILL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUTURES INDIA PVT., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNILENE S.A.C.
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 222
No code available 76
Other (for use when an appropriate device code cannot be identified) 37
Failure to Adhere or Bond 31
Needle, separation 13
Detachment of device component 10
No Known Device Problem 8
Material integrity issue 8
Reaction 8
Battery charger, defective 6
Defective item 5
Material frayed 4
Unknown (for use when the device problem is not known) 4
Kinked 3
Component(s), broken 3
Detachment of device or device component 3
Tear, rip or hole in device packaging 2
Material twisted 2
Difficult to open or remove packaging material 2
Manufacturing or shipping issue associated with device 2
Packaging issue 2
Failure to unfold or unwrap 2
Bent 2
Defective component 2
Component missing 1
Out-of-box failure 1
Material fragmentation 1
Product quality issue 1
Melted 1
Migration of device or device component 1
Dull 1
Device remains implanted 1
Tip breakage 1
Device misassembled during manufacturing or shipping 1
Device operates differently than expected 1
Total Device Problems 468

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 0 0 1 1 1 0 3 4 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 C P Medical II Sep-27-2010
2 C P Medical Inc. II Jun-03-2014
3 C P Medical Inc. II Nov-19-2011
4 C P Medical, Inc. II Oct-27-2014
5 DePuy Mitek, Inc., a Johnson & Johnson Co. II Apr-25-2013
6 Ethicon, Inc. II Dec-06-2013
7 Ethicon, Inc. II May-12-2009
8 Riverpoint Medical, LLC II Nov-18-2013
9 Teleflex Medical II May-01-2014
10 Teleflex Medical II Apr-25-2014

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