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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 14
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 5
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 59
  1.  K002684  COMPOSIX E/X MESH
  2.  K003323  COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203 ...
  3.  K003990  SOFRADIM PARIETEX SURGICAL MESHES
  4.  K021736  BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 00103 ...
  5.  K022350  BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
  6.  K024008  SMALL BARD VENTRALEX PATCH
  7.  K033376  UGYTEX MESH
  8.  K033814  BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, ...
  9.  K040998  MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
  10.  K042026  BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0 ...
  11.  K050187  PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
  12.  K052155  BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
  13.  K061314  BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
  14.  K061754  BARD COMPOSITE L/P MESH
  15.  K071629  PARIETEX POLYESTER MESH WITH INTRODUCER
  16.  K073287  PREVADH MESH
  17.  K081010  BARD 3DMAX MESH
  18.  K081050  PARIETEX PROGRIP MESH
  19.  K081126  PARIETEX COMPOSITE MONO PM MESH
  20.  K081777  VENTRIO HERNIA PATCH
  21.  K090858  PARIETEX MONOFILAMENT POLYESTER MESH
  22.  K091659  BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0 ...
  23.  K092032  BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0 ...
  24.  K100229  VENTRIO HERNIA PATCH
  25.  K101197  PARIE TENE PROGRIP MESH
  26.  K101519  PARIETEX PLUG AND PATCH
  27.  K101851  VENTRALIGHT ST MESH
  28.  K101920  VENTRIO ST HERNIA PATCH
  29.  K101928  VENTRALEX ST HERNIA PATCH
  30.  K102766  COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
  31.  K103682  PARIETEX PROGRIP
  32.  K110663  PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCE ...
  33.  K110815  PARIETEX OPTIMIZED COMPOSTIE MESH
  34.  K110816  PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFEREN ...
  35.  K110820  VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIO ...
  36.  K113229  VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL ...
  37.  K120506  PARIETEX COMPOSITE VENTRAL PATCH
  38.  K120897  PROGRIP LAPARSCOPIC SELF-FIXATING MESH
  39.  K122436  COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM ...
  40.  K123479  PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
  41.  K130968  VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTE ...
  42.  K131969  SYMBOTEX(TM) COMPOSITE MESH
  43.  K132441  BARD VENTRALEX HERNIA PATCH
  44.  K140941  PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETEN ...
  45.  K142091  PARIETENE MACROPOROUS MESH
  46.  K142706  Modified ONFLEX Mesh
  47.  K142711  ONFLEX Mesh
  48.  K142900  Parietex Progrip Mesh (new name: Progrip Self-Grip ...
  49.  K142908  Parietex Monofilament Polyester Mesh (new name: Pa ...
  50.  K143386  Progrip Laparoscopic Self-Fixating Mesh
  51.  K143743  ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
  52.  K150091  Versatex Monofilament Mesh
  53.  K153236  Small PerFix Light Plug with 6 x 13.5 cm HydroLigh ...
  54.  K792281  USHER'S MARLEX TUBULAR MESH
  55.  K922916  BARD MARLEX MESH DART
  56.  K953577  BARD VISILEX MESH 3 X 6
  57.  K971745  BARD COMPOSITE PROSTHESIS
  58.  K991400  PARIETENE POLYPROPYLENE MESH
  59.  K991637  BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 01 ...
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 4
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
ENDOGUN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ETHICON
  SUBSTANTIALLY EQUIVALENT 18
EVERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
  SUBSTANTIALLY EQUIVALENT 2
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 10622
Other (for use when an appropriate device code cannot be identified) 1990
Material erosion 1588
No Information 691
Migration of device or device component 633
No code available 377
Detachment of device component 323
Unknown (for use when the device problem is not known) 301
Defective item 285
Tears, rips, holes in device, device material 159
Device remains implanted 140
Break 103
Material perforation 96
Implant, removal of 68
Material deformation 40
Device or device fragments location unknown 34
Torn material 27
Extrusion 24
Reaction 24
Needle, separation 23
Difficult to advance 23
Implant extrusion 22
Detachment of device or device component 21
Bent 21
Component(s), broken 20
Difficult to insert 20
Explanted 18
Failure to Adhere or Bond 17
Unsealed device packaging 17
Material separation 16
Difficult to deploy 16
Material frayed 16
Folded 15
Tear, rip or hole in device packaging 15
Material disintegration 14
Hole in material 14
Suture line disruption 13
Device operates differently than expected 12
Premature deployment 12
Material rupture 11
Contamination during use 11
Patient-device incompatibility 11
Device Issue 11
Not Applicable 10
Failure to deploy 9
Difficult to remove 9
Difficult to position 9
Obstruction within device 8
Dislodged or dislocated 7
Material rigid or stiff 7
Material twisted 7
Device expiration issue 6
Buckled material 6
Malposition of device 6
Split 6
Use of Device Issue 5
Bacterial contamination of device 5
Foreign material present in device 5
Device, or device fragments remain in patient 5
Product quality issue 5
User used incorrect product for intended use 4
Slippage of device or device component 4
Device Difficult to Setup or Prepare 4
Kinked 4
Dislodged 4
Material integrity issue 4
Device packaging compromised 4
Stretched 4
Implant, repositioning of 4
Malfunction 3
Sterility 3
Sticking 3
Fitting problem 3
Device damaged prior to use 3
Misfire 3
Delivery System Issue, No Description 3
Human-Device Interface Issue 3
Degraded 3
Leak 3
Material fragmentation 3
Misapplication 3
Source, detachment from 3
Incorrect or inadequate result 3
Retraction problem 3
Size incorrect for patient 2
Delivered as unsterile product 2
Normal 2
Fracture 2
Loose 2
Energy spectrum incorrect 2
Crack 2
Loss of or failure to bond 2
Material Protrusion 2
Packaging issue 2
Deployment issue 2
Device or device component damaged by another device 2
Device markings issue 2
Out-of-box failure 2
Improper or incorrect procedure or method 2
Unexpected therapeutic results 2
Total Device Problems 18142

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 1 0 0 1 0 0 0 0 0 0
Class II 0 0 0 4 8 3 2 2 3 0
Class III 0 0 2 0 0 1 0 0 0 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 Atrium Medical Corporation II Aug-09-2013
6 Boston Scientific Corporation II Aug-03-2011
7 Coloplast Manufacturing US, LLC III May-02-2012
8 Covidien LP II Feb-01-2011
9 Davol, Inc., Sub. C. R. Bard, Inc. II Nov-01-2011
10 Davol, Inc., Sub. C. R. Bard, Inc. II May-23-2011
11 Davol, Inc., Sub. C. R. Bard, Inc. II May-02-2011
12 Davol, Inc., Sub. C. R. Bard, Inc. II Nov-23-2010
13 Davol, Inc., Sub. C. R. Bard, Inc. II Nov-19-2010
14 Davol, Inc., Sub. C. R. Bard, Inc. II May-04-2010
15 Davol, Inc., Sub. C. R. Bard, Inc. III Jan-28-2009
16 Davol, Inc., Sub. C. R. Bard, Inc. I Jan-30-2007
17 Davol, Inc., Subs. C. R. Bard, Inc. II Nov-07-2014
18 Davol, Inc., Subs. C. R. Bard, Inc. II Jan-23-2014
19 Davol, Inc., Subs. C. R. Bard, Inc. II Sep-20-2012
20 EXP Pharmaceutical Services Corp II Jul-24-2015
21 Ethicon, Inc. II Jan-14-2011
22 Generic Medical Devices II Feb-22-2011
23 Generic Medical Devices III Nov-16-2009
24 MAST Biosurgery USA, Inc II Feb-10-2015
25 Novomedicus Llc II Jan-27-2012
26 Ram Medical Inc I Jun-08-2010
27 Stryker Craniomaxillofacial Division II Feb-11-2015

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