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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bender
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXW
Regulation Number 888.4540
Device Class 1

Device Problems
Fracture 13
Device inoperable 8
Break 7
Disassembly 1
Component missing 1
Mechanical jam 1
Material fragmentation 1
Loose or intermittent connection 1
Device maintenance issue 1
Sticking 1
Total Device Problems 35

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

Recalls
Manufacturer Recall Class Date Posted
1 Synthes, Inc. II Jan-28-2015

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