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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ankle arthroplasty implantation system
Regulation Description Ankle joint metal/polymer semi-constrained cemented prosthesis.
Definition Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
Product CodeOYK
Regulation Number 888.3110
Device Class 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Mar-02-2012

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