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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extractor
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWB
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 33
Malfunction 5
Unknown (for use when the device problem is not known) 4
Break 4
Component(s), broken 1
Disassembly 1
Device, or device fragments remain in patient 1
Tip breakage 1
Interlock(s), failure of 1
Total Device Problems 51

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 2 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Dec-28-2010
2 Stryker Howmedica Osteonics Corp. II Apr-27-2010

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