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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bit, surgical
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFG
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
SPIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 15
Unknown (for use when the device problem is not known) 11
Material fragmentation 2
Total Device Problems 28

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

Recalls
Manufacturer Recall Class Date Posted
1 Synthes, Inc. II May-29-2014

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