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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, fixation, proximal femoral, implant
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDO
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STELKAST
  1
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Information 8
No code available 7
Fracture 5
Component(s), broken 3
No Known Device Problem 3
Break 2
Cable break 1
Mechanical issue 1
Tear, rip or hole in device packaging 1
Failure to separate 1
Mechanical jam 1
Total Device Problems 33

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

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer, Inc. II Feb-20-2014

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