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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, surgical instrument, pneumatic powered
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGET
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 14
Difficult to open or close 6
Torn material 3
Failure to align 2
Burst 2
Fracture 1
Peeled 1
Material separation 1
Material integrity issue 1
Material Protrusion 1
Mechanics altered 1
Defective item 1
Detachment of device or device component 1
No Information 1
Total Device Problems 36

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

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Jan-03-2014
2 Linvatec Corp. II Jan-15-2009
3 MicroAire Surgical Instruments, LLC II May-27-2016

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