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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone wedge
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Product CodePLF
Regulation Number 888.3030
Device Class 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jun-14-2016

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