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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device saw, powered, and accessories
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHAB
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Metal shedding debris 50
No Known Device Problem 6
Break 4
Device Issue 3
Foreign material present in device 3
Total Device Problems 66

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 0 1 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ascent Healthcare Solutions, Inc. II Sep-19-2008
2 Smith & Nephew, Inc. Endoscopy Division II Jul-01-2011

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