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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chair, with casters
Regulation Description Mechanical chair.
Product CodeINM
Regulation Number 890.3100
Device Class 1


Premarket Reviews
ManufacturerDecision
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
WINCO, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Use of Device Issue 10
Break 9
Detachment of device component 8
Product quality issue 7
No Known Device Problem 7
Unintended movement 6
Defective component 6
Tipover 6
Component(s), broken 3
Fracture 3
Component(s), worn 2
Collapse 2
Improper or incorrect procedure or method 2
Device Issue 1
Structural problem 1
Folded 1
Buckled material 1
Electrical shorting 1
No Information 1
Bent 1
Channeling 1
Crack 1
Electrical issue 1
Fail-safe design failure 1
Material fragmentation 1
Hole in material 1
Overheating of device or device component 1
Reuse 1
Material separation 1
Size incorrect for patient 1
Device inoperable 1
Unstable 1
Total Device Problems 90

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 1 0 3 1 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Nemschoff Chairs, Inc. II Oct-06-2014
2 Winco Mfg., LLC II Feb-26-2014
3 Winco Mfg., LLC II Feb-04-2013
4 Winco Mfg., LLC II Oct-10-2012
5 Winco Mfg., LLC II Apr-25-2012
6 Winco Mfg., LLC II Feb-26-2012
7 Winco, Inc. II Oct-27-2010

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