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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device retractor, self-retaining
Regulation Description Manual gastroenterology-urology surgical instrument and accessories.
Product CodeFFO
Regulation Number 876.4730
Device Class 1


Premarket Reviews
ManufacturerDecision
KENDALL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unintended movement 11
Break 10
Dislodged or dislocated 9
Slippage of device or device component 2
Component or accessory incompatibility 2
Device misassembled during manufacturing or shipping 1
Other (for use when an appropriate device code cannot be identified) 1
Contamination during use 1
Device maintenance issue 1
Mechanical issue 1
Shipping damage or problem 1
Foreign material present in device 1
No code available 1
Total Device Problems 42

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

Recalls
Manufacturer Recall Class Date Posted
1 Abeon Medical Corporation II Jan-21-2016

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