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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, composite/metal
Regulation Description Hip joint metal/composite semi-constrained cemented prosthesis.
Product CodeKMC
Regulation Number 888.3340
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

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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