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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, polymeric
Regulation Description Surgical mesh.
Product CodeFTL
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ALURE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ANULEX TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTIMPLANT AB
  SUBSTANTIALLY EQUIVALENT 2
ASPIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 12
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 5
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 47
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
ENDOGUN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 16
EVERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
  SUBSTANTIALLY EQUIVALENT 1
FUSION MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
GENERIC MEDICAL DEVICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
GESELLSCHAFT
  SUBSTANTIALLY EQUIVALENT 1
HERNIAMESH S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTECH ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 2
MAST BIOSURGERY USA INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
MINNESOTA MEDICAL DEVELOPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
ORGANOGENESIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEGASUS
  SUBSTANTIALLY EQUIVALENT 1
POLYGANICS BV
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROXY BIOMEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 4
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHELHIGH, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECIALTY SURGICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
SUTURES INDIA PVT., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 2
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE SCIENCE LABORATORIES, PLC
  SUBSTANTIALLY EQUIVALENT 2
TISSUE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
TORNIER
  SUBSTANTIALLY EQUIVALENT 3
TYRX
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 5
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 35

Device Problems
No Known Device Problem 4148
Other (for use when an appropriate device code cannot be identified) 1939
Material erosion 1164
Detachment of device component 318
Unknown (for use when the device problem is not known) 301
Tears, rips, holes in device, device material 157
Device remains implanted 139
No Information 106
Material perforation 95
Implant, removal of 68
Break 52
Device or device fragments location unknown 33
No code available 27
Needle, separation 23
Reaction 23
Difficult to advance 23
Implant extrusion 21
Component(s), broken 20
Difficult to insert 20
Bent 19
Difficult to deploy 16
Explanted 15
Migration of device or device component 13
Unsealed device packaging 13
Suture line disruption 13
Material frayed 12
Premature deployment 12
Torn material 12
Material deformation 10
Difficult to position 9
Difficult to remove 9
Failure to deploy 9
Device Issue 8
Not Applicable 8
Obstruction within device 7
Material disintegration 7
Malposition of device 6
Extrusion 5
Tear, rip or hole in device packaging 5
Failure to Adhere or Bond 5
Material separation 5
Device, or device fragments remain in patient 5
Material twisted 5
Patient-device incompatibility 5
Dislodged or dislocated 4
Split 4
Implant, repositioning of 4
Stretched 4
Device expiration issue 4
Retraction problem 4
Dislodged 4
Product quality issue 4
Misapplication 3
Leak 3
Fitting problem 3
Device damaged prior to use 3
Malfunction 3
Misfire 3
Source, detachment from 3
Device packaging compromised 3
Delivery System Issue, No Description 3
Sterility 3
Material rigid or stiff 2
Energy spectrum incorrect 2
Fracture 2
Material fragmentation 2
Folded 2
Failure to separate 2
Device Difficult to Setup or Prepare 2
Delivered as unsterile product 2
Kinked 2
Foreign material present in device 2
Loose 2
Improper or incorrect procedure or method 2
Normal 2
Peeled 1
Decrease in pressure 1
Source, incorrect 1
Tip breakage 1
Error or warning message, failure to produce 1
Failure to capture 1
Disengaged 1
Incompatibility problem 1
Seal, defective 1
Loose or intermittent connection 1
Needle, dull 1
Displacement 1
Replace 1
Material rupture 1
Extrusion, impending 1
Material puncture 1
Bacterial contamination of device 1
Film processing, inadequate 1
Nonstandard device or device component 1
Balloon leak(s) 1
Loss of or failure to bond 1
Crack 1
Use of Device Issue 1
Inaccurate delivery 1
Defective item 1
Total Device Problems 9023

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 1 0 0 1 0 0 0
Class II 0 0 0 4 8 3 1
Class III 0 0 2 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Allergen Medical II Feb-07-2013
2 American Medical Systems, Inc. II Nov-07-2012
3 American Medical Systems, Inc. II Jul-07-2011
4 American Medical Systems, Inc. II Dec-27-2010
5 Boston Scientific Corporation II Aug-03-2011
6 Coloplast Manufacturing US, LLC III May-02-2012
7 Covidien LP II Feb-01-2011
8 Davol, Inc., Sub. C. R. Bard, Inc. II Nov-01-2011
9 Davol, Inc., Sub. C. R. Bard, Inc. II May-23-2011
10 Davol, Inc., Sub. C. R. Bard, Inc. II May-02-2011
11 Davol, Inc., Sub. C. R. Bard, Inc. II Nov-23-2010
12 Davol, Inc., Sub. C. R. Bard, Inc. II Nov-19-2010
13 Davol, Inc., Sub. C. R. Bard, Inc. II May-04-2010
14 Davol, Inc., Sub. C. R. Bard, Inc. III Jan-28-2009
15 Davol, Inc., Sub. C. R. Bard, Inc. I Jan-30-2007
16 Davol, Inc., Subs. C. R. Bard, Inc. II Sep-20-2012
17 Ethicon, Inc. II Jan-14-2011
18 Generic Medical Devices II Feb-22-2011
19 Generic Medical Devices III Nov-16-2009
20 Novomedicus Llc II Jan-27-2012
21 Ram Medical Inc I Jun-08-2010

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