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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
ACELL, INC
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 7
BRENNEN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 14
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 6
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORGANOGENESIS, INC.
  SUBSTANTIALLY EQUIVALENT 6
PEGASUS
  SUBSTANTIALLY EQUIVALENT 2
PNEUMEX, INC.
  SUBSTANTIALLY EQUIVALENT 3
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTI Biologics, Inc.
  SUBSTANTIALLY EQUIVALENT 3
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 6
SHELHIGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS SURGICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 6
TI-MESH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE SCIENCE LABORATORIES, PLC
  SUBSTANTIALLY EQUIVALENT 3
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XYLOS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
No Known Device Problem 353
Needle, separation 158
Unknown (for use when the device problem is not known) 84
Detachment of device component 69
Difficult to insert 20
Other (for use when an appropriate device code cannot be identified) 17
Device or device fragments location unknown 15
Split 15
Device, or device fragments remain in patient 13
Material erosion 8
Tears, rips, holes in device, device material 6
Implant, removal of 5
Component(s), broken 5
Malfunction 5
Bent 4
Misplacement 4
Suture line separation 3
Break 3
Explanted 3
Mechanical issue 3
Material fragmentation 3
Torn material 3
Material frayed 2
Misassembled 2
Twisting 2
Device Issue 2
Device remains implanted 2
Difficult to position 2
Retraction problem 2
Sticking 1
Difficult to remove 1
Rejection 1
Material perforation 1
Use of Device Issue 1
Membrane tear(s) 1
Misapplication 1
Kinked 1
Foreign material 1
Error or warning message, failure to produce 1
Crack 1
No Information 1
Misfire 1
Failure to separate 1
Total Device Problems 827

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

Recalls
Manufacturer Recall Class Date Posted
1 ACell, Inc II Jul-21-2011
2 American Medical Systems III Jan-27-2009
3 Davol, Inc., Sub. C. R. Bard, Inc. I Mar-02-2011
4 Ethicon, Inc. II May-10-2007
5 Howmedica Osteonics Corp dba Stryker Craniomaxillofacial II Jan-27-2012
6 LifeCell Corporation II Nov-09-2011
7 LifeCell Corporation III Sep-29-2010
8 Synovis Surgical Inovation Div. of III Nov-23-2011
9 Synovis Surgical Inovation Div. of II Jun-15-2007

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