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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
  1.  K073219  WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89X ...
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 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 1085
No Information 201
Migration of device or device component 198
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
Hole in material 6
Material rupture 6
Tears, rips, holes in device, device material 6
Malfunction 5
Implant, removal of 5
Torn material 5
Component(s), broken 5
Explanted 4
Degraded 4
Material disintegration 4
Bent 4
Break 4
Misplacement 4
Bacterial contamination of device 4
Suture line separation 3
Mechanical issue 3
Contamination during use 3
Material fragmentation 3
Material frayed 2
Misassembled 2
Difficult to position 2
Incorrect or inadequate result 2
Retraction problem 2
Rejection 2
Device remains implanted 2
Twisting 2
Device Issue 2
Dislodged or dislocated 2
Foreign material present in device 1
Incomplete or missing packaging 1
Misfire 1
Failure to separate 1
Failure to form staple 1
Failure to unfold or unwrap 1
Use of Device Issue 1
Material perforation 1
Difficult to remove 1
Sticking 1
Product quality issue 1
Membrane tear(s) 1
Misapplication 1
Foreign material 1
Kinked 1
Crack 1
Entrapment of device or device component 1
Error or warning message, failure to produce 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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