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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aid, transfer
Regulation Description Daily activity assist device.
Product CodeIKX
Regulation Number 890.5050
Device Class 1

Device Problems
Break 79
Use of Device Issue 28
Detachment of device component 21
Buckled material 18
Product quality issue 16
Collapse 15
Bent 12
No Known Device Problem 10
Crack 10
Other (for use when an appropriate device code cannot be identified) 6
Inaccurate delivery 6
Detachment of device or device component 5
Fracture 4
Unstable 4
User used incorrect product for intended use 3
Inadequate training 3
Material separation 2
Device Issue 2
Folded 2
Fluid leak 2
Improper or incorrect procedure or method 2
Defective component 2
Melted 2
Connector pin failure 1
Unknown (for use when the device problem is not known) 1
Mechanical issue 1
Torn material 1
No Information 1
Misassembled by Users 1
Device handling issue 1
Out-of-box failure 1
Difficult to fold or unfold 1
Shaft break 1
Fitting problem 1
Total Device Problems 265

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

Recalls
Manufacturer Recall Class Date Posted
1 AliMed Corporation II Jan-22-2009
2 Handicare USA, Inc. II May-14-2015
3 North Coast Medical Inc II Apr-16-2012
4 Nutech Manufacturing Corp II Dec-01-2009
5 Zimmer Inc. II Sep-16-2008

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