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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bur, surgical, general & plastic surgery
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFF
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KOMET MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 18
Overheating of device or device component 9
Device operates differently than expected 5
Device inoperable 2
Component falling 2
Difficult to insert 2
Material separation 2
Device packaging compromised 1
Foreign material present in device 1
Malposition of device 1
Manufacturing or shipping issue associated with device 1
Disconnection 1
Failure to shut off 1
Temperature issue 1
Mechanical issue 1
Material discolored 1
Tear, rip or hole in device packaging 1
Bent 1
Dislodged or dislocated 1
Total Device Problems 52

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 1 0 0 0 1 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 Linvatec Corp. II Apr-08-2008
3 Sterilmed Inc II Jan-13-2009
4 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
5 The Anspach Effort, Inc. II Jan-27-2014
6 The Anspach Effort, Inc. II Jan-06-2014

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