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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blade, saw, surgical, cardiovascular
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeDWH
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K904352  CODMAN COLLINS RADIOPARENT STERNAL BLADES

Device Problems
Device inoperable 21
Break 10
Other (for use when an appropriate device code cannot be identified) 4
Connection error 2
Motor failure 2
Failure, intermittent 1
Fracture 1
Failure to cut 1
Device operates differently than expected 1
Noise 1
Total Device Problems 44

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

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Feb-07-2012

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