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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
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 10608
Other (for use when an appropriate device code cannot be identified) 1990
Material erosion 1588
No Information 643
Migration of device or device component 633
No code available 365
Detachment of device component 323
Unknown (for use when the device problem is not known) 301
Defective item 244
Tears, rips, holes in device, device material 159
Device remains implanted 140
Break 100
Material perforation 96
Implant, removal of 68
Material deformation 40
Device or device fragments location unknown 34
Torn material 26
Reaction 24
Extrusion 24
Difficult to advance 23
Needle, separation 23
Implant extrusion 22
Bent 21
Detachment of device or device component 20
Component(s), broken 20
Difficult to insert 20
Explanted 18
Failure to Adhere or Bond 17
Difficult to deploy 16
Material frayed 16
Unsealed device packaging 16
Material separation 16
Folded 15
Hole in material 14
Suture line disruption 13
Premature deployment 12
Tear, rip or hole in device packaging 12
Material disintegration 12
Patient-device incompatibility 11
Device operates differently than expected 11
Contamination during use 11
Device Issue 11
Not Applicable 10
Difficult to remove 9
Failure to deploy 9
Difficult to position 9
Material rupture 9
Obstruction within device 8
Dislodged or dislocated 7
Material twisted 7
Material rigid or stiff 7
Malposition of device 6
Device expiration issue 6
Buckled material 6
Use of Device Issue 5
Device, or device fragments remain in patient 5
Product quality issue 5
Bacterial contamination of device 5
Split 5
Foreign material present in device 5
Dislodged 4
User used incorrect product for intended use 4
Device packaging compromised 4
Stretched 4
Kinked 4
Material integrity issue 4
Implant, repositioning of 4
Device Difficult to Setup or Prepare 4
Degraded 3
Retraction problem 3
Misfire 3
Sterility 3
Human-Device Interface Issue 3
Delivery System Issue, No Description 3
Device damaged prior to use 3
Malfunction 3
Incorrect or inadequate result 3
Slippage of device or device component 3
Source, detachment from 3
Material fragmentation 3
Misapplication 3
Fitting problem 3
Leak 3
Loose 2
Size incorrect for patient 2
Sticking 2
Normal 2
Device or device component damaged by another device 2
Failure to separate 2
Out-of-box failure 2
Material Protrusion 2
Crack 2
Packaging issue 2
Device markings issue 2
Fracture 2
Energy spectrum incorrect 2
Unexpected therapeutic results 2
Device inoperable 2
Improper or incorrect procedure or method 2
Delivered as unsterile product 2
Total Device Problems 18010

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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