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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table, surgical with orthopedic accessories, ac-powered
Regulation Description Operating tables and accessories and operating chairs and accessories.
Product CodeJEA
Regulation Number 878.4960
Device Class 1


Premarket Reviews
ManufacturerDecision
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SKYTRON
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Issue 4
Failure to advance 3
Mechanical issue 3
Patient-device incompatibility 3
Unintended movement 3
No Information 2
Use of Device Issue 2
Improper or incorrect procedure or method 1
Tipover 1
Unintended system motion 1
Break 1
Detachment of device component 1
Device handling issue 1
Device operates differently than expected 1
Maintenance does not comply to manufacturers recommendations 1
Material twisted 1
No Known Device Problem 1
Positioning Issue 1
Total Device Problems 31

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 1 0 0 0 1 0 1 1 1 2
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Mizuho OSI II Feb-13-2013
2 Mizuho Orthopedic Systems Inc I Oct-27-2011
3 Mizuho Orthopedic Systems Inc II Jan-20-2011
4 Mizuho Orthopedic Systems Inc II Dec-13-2007
5 Steris Corporation II Jul-20-2016
6 Trumpf Medical Systems III Nov-05-2013
7 Trumpf Medical Systems, Inc. II Feb-05-2016
8 Trumpf Medical Systems, Inc. II Jan-06-2015
9 Trumpf Medical Systems, Inc. II Oct-27-2014

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