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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device driver, prosthesis
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWR
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fracture 5
Difficult to remove 2
Break 2
Device or device fragments location unknown 1
Total Device Problems 10

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Apr-11-2010
2 Pioneer Surgical Technology II Nov-27-2007
3 Wright Medical Technology Inc II Nov-27-2007

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