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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 3
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 5
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 16
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 6
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 7
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 1169
No Information 219
No code available 207
Needle, separation 158
Migration of device or device component 148
Unknown (for use when the device problem is not known) 84
Detachment of device component 72
Other (for use when an appropriate device code cannot be identified) 27
Device operates differently than expected 22
Split 21
Difficult to insert 20
Device or device fragments location unknown 16
Device, or device fragments remain in patient 13
Material erosion 10
Degraded 8
Hole in material 8
Break 7
Material rupture 7
Tears, rips, holes in device, device material 6
Torn material 6
Material disintegration 6
Component(s), broken 5
Bacterial contamination of device 5
Implant, removal of 5
Malfunction 5
Misplacement 4
Bent 4
Contamination during use 4
Explanted 4
Material fragmentation 3
Mechanical issue 3
Suture line separation 3
Device Issue 3
Defective item 3
Dislodged or dislocated 3
Foreign material present in device 2
Twisting 2
Use of Device Issue 2
Device emits odor 2
Difficult to position 2
Misassembled 2
Rejection 2
Device remains implanted 2
Incorrect or inadequate result 2
Retraction problem 2
Material frayed 2
Flaked 2
Foreign material 1
Error or warning message, failure to produce 1
Device expiration issue 1
Kinked 1
Crack 1
Entrapment of device or device component 1
Failure to Adhere or Bond 1
Material rigid or stiff 1
Difficult to remove 1
Product quality issue 1
Membrane tear(s) 1
Misapplication 1
Failure to unfold or unwrap 1
Sticking 1
Tear, rip or hole in device packaging 1
Misfire 1
Incomplete or missing packaging 1
Material perforation 1
Human-Device Interface Issue 1
Material deformation 1
Material Protrusion 1
Failure to separate 1
Failure to form staple 1
Device packaging compromised 1
Total Device Problems 2336

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 0 0 0 0 0
Class II 2 0 0 0 2 1 0 1 0 0 0
Class III 0 0 1 1 1 0 0 0 0 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 Apr-03-2014
5 Ethicon, Inc. II May-10-2007
6 Howmedica Osteonics Corp dba Stryker Craniomaxillofacial II Jan-27-2012
7 LifeCell Corporation II Nov-09-2011
8 LifeCell Corporation III Sep-29-2010
9 Synovis Surgical Inovation Div. of III Nov-23-2011
10 Synovis Surgical Inovation Div. of II Jun-15-2007

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