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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 57
Buckled material 17
Product quality issue 16
Collapse 15
Bent 9
Crack 8
Detachment of device component 6
Other (for use when an appropriate device code cannot be identified) 6
Inaccurate delivery 6
Fracture 4
Unstable 2
Folded 2
Fitting problem 1
Unknown (for use when the device problem is not known) 1
No Known Device Problem 1
Misassembled by Users 1
No Information 1
Shaft break 1
Connector pin failure 1
Total Device Problems 155

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 2 0 0 1 0
Class III 0 0 0 0 0 0 0

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

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