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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction
Regulation Description Polytetrafluoroethylene with carbon fibers composite implant material.
Product CodeKKY
Regulation Number 878.3500
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CEREMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 9
Fracture 7
Fitting problem 6
No Known Device Problem 6
Size incorrect for patient 4
Device markings issue 4
Migration of device or device component 4
Material fragmentation 3
Patient-device incompatibility 3
Break 2
Crack 1
Difficult to position 1
Device, or device fragments remain in patient 1
Shelf life exceeded 1
Device packaging compromised 1
Dislodged or dislocated 1
Manufacturing or shipping issue associated with device 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Structural problem 1
Total Device Problems 58

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, LLC II Sep-08-2016
2 Matrix Surgical Holdings, LLC II Feb-28-2017
3 Stryker Craniomaxillofacial Division I Dec-18-2008
4 Stryker Howmedica Osteonics Corp. II Feb-12-2014

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