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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, metal
Regulation Description Surgical mesh.
Product CodeEZX
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 3
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SE - WITH LIMITATIONS 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect device or component shipped 2
Packaging issue 2
No Known Device Problem 2
Unknown (for use when the device problem is not known) 2
Explanted 1
Migration of device or device component 1
Torn material 1
Collapse 1
Device Issue 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Oct-30-2015

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