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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 15
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K001738  DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
  2.  K031969  DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
  3.  K071016  DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
  4.  K982330  DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE ...
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 5
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 1084
No Information 201
Migration of device or device component 199
Needle, separation 158
Unknown (for use when the device problem is not known) 84
Detachment of device component 69
No code available 46
Other (for use when an appropriate device code cannot be identified) 29
Split 21
Difficult to insert 20
Device operates differently than expected 18
Device or device fragments location unknown 15
Device, or device fragments remain in patient 13
Material erosion 10
Material rupture 6
Hole in material 6
Tears, rips, holes in device, device material 6
Malfunction 5
Torn material 5
Implant, removal of 5
Component(s), broken 5
Break 4
Bacterial contamination of device 4
Misplacement 4
Bent 4
Material disintegration 4
Degraded 4
Explanted 4
Contamination during use 3
Suture line separation 3
Material fragmentation 3
Mechanical issue 3
Difficult to position 2
Incorrect or inadequate result 2
Device remains implanted 2
Device Issue 2
Rejection 2
Retraction problem 2
Dislodged or dislocated 2
Material frayed 2
Misassembled 2
Twisting 2
Misfire 1
Membrane tear(s) 1
Use of Device Issue 1
Product quality issue 1
Foreign material 1
Difficult to remove 1
Failure to separate 1
Failure to form staple 1
Incomplete or missing packaging 1
Foreign material present in device 1
Error or warning message, failure to produce 1
Misapplication 1
Sticking 1
Failure to unfold or unwrap 1
Crack 1
Material perforation 1
Entrapment of device or device component 1
Kinked 1
Total Device Problems 2083

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 0 0 0 0
Class II 2 0 0 0 2 1 0 1 0 0
Class III 0 0 1 1 1 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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