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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, operating-room, table (kit)
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Product CodeFWZ
Regulation Number 878.4950
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ALLEN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 18
Mechanical issue 15
Use of Device Issue 13
Device Issue 7
Loose or intermittent connection 7
No Known Device Problem 7
Device handling issue 6
Component falling 6
Defective component 6
Detachment of device component 5
Unintended movement 5
Fracture 4
Unintended head motion 3
Melted 3
Overheating of device or device component 3
Break 3
Other (for use when an appropriate device code cannot be identified) 2
Table, tilting 2
Unstable 2
Failure to advance 2
Tipover 2
Markings unclear 2
Detachment of device or device component 2
Not Applicable 2
No code available 1
Positioning Issue 1
Material deformation 1
Material integrity issue 1
Patient-device incompatibility 1
Improper or incorrect procedure or method 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Circuit Failure 1
Bent 1
Crack 1
Disconnection 1
Fail-safe design failure 1
Device remains activated 1
Slippage of device or device component 1
Device maintenance issue 1
Total Device Problems 144

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 2 0 0
Class II 1 0 3 1 0 3 2 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc I Dec-16-2014
2 Customed, Inc I Aug-29-2014
3 Integra LifeSciences Corp. II Feb-21-2013
4 Integra LifeSciences Corporation II Feb-10-2015
5 Integra LifeSciences Corporation II Dec-19-2012
6 Integra LifeSciences Corporation II Sep-09-2010
7 Integra Limited II Sep-26-2012
8 MAQUET Inc. II Jan-15-2009
9 Maquet Cardiovascular Us Sales, Llc II Nov-09-2015
10 Maquet Inc. II Jan-03-2013
11 Maquet Inc. II Dec-02-2009
12 Mizuho Orthopedic Systems Inc II Mar-13-2012
13 Orthopedic Systems Inc II May-04-2007
14 Sterilmed Inc II Jan-13-2009

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