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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hammer, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeFZY
Regulation Number 878.4800
Device Class 1

Device Problems
Break 16
Mechanical jam 2
No code available 1
Crack 1
Metal shedding debris 1
Dull 1
Dent in material 1
Detachment of device or device component 1
Material deformation 1
Total Device Problems 25

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

Recalls
Manufacturer Recall Class Date Posted
1 EBI, L.P. II Sep-16-2008
2 SpineFrontier, Inc. II Aug-01-2013

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