• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 516
No code available 212
Failure to Adhere or Bond 83
Detachment of device component 66
Other (for use when an appropriate device code cannot be identified) 37
Tear, rip or hole in device packaging 23
Needle, separation 13
Not Applicable 11
No Known Device Problem 8
Bent 8
Reaction 8
Material integrity issue 8
Defective item 7
Kinked 7
Battery charger, defective 6
Material frayed 5
Component incompatible 5
Migration of device or device component 5
Product quality issue 5
Detachment of device or device component 4
Unknown (for use when the device problem is not known) 4
Packaging issue 4
Device operates differently than expected 3
Difficult to open or remove packaging material 3
Material twisted 3
Component(s), broken 3
Material fragmentation 2
Leak 2
Loose or intermittent connection 2
Failure to unfold or unwrap 2
Manufacturing or shipping issue associated with device 2
Device misassembled during manufacturing or shipping 2
Defective component 2
Component missing 2
Out-of-box failure 1
Device remains implanted 1
Tip breakage 1
Dull 1
Incorrect device or component shipped 1
Melted 1
Knotted 1
Nonstandard device or device component 1
Unsealed device packaging 1
Total Device Problems 1082

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 1 1 1 0 3 4 0 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 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

-
-