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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wax,bone
Product CodeMTJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
CEREMED, INC.
  SUBSTANTIALLY EQUIVALENT 6
Hemostasis, LLC
  SUBSTANTIALLY EQUIVALENT 1
MARINE POLYMER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Reaction 5
No code available 4
No Known Device Problem 3
Chemical issue 1
Failure to Adhere or Bond 1
Migration of device or device component 1
Device markings issue 1
Incomplete or missing packaging 1
Total Device Problems 17

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 0 0
Class II 0 0 1 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 Ethicon, Inc. II Mar-04-2009
2 Synthes USA HQ, Inc. I Aug-16-2012
3 Synthes, Inc. II Feb-11-2015

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