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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
Break 107
Fracture 37
Material fragmentation 19
Device operates differently than expected 9
No code available 9
Material deformation 6
Malfunction 5
Metal shedding debris 5
Fitting problem 5
Unknown (for use when the device problem is not known) 4
Bent 4
Disassembly 3
Mechanical jam 3
No Known Device Problem 2
Dull 2
Interlock(s), failure of 1
Failure to align 1
Detachment of device or device component 1
Material integrity issue 1
Component(s), broken 1
Loose or intermittent connection 1
Peeled 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Tip breakage 1
Total Device Problems 230

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