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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device knee arthroplasty implantation system
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Product CodeOOG
Regulation Number 888.3560
Device Class 2

Device Problems
No Known Device Problem 2
No Information 1
Unstable 1
Malposition of device 1
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 ConforMIS, Inc. II Oct-21-2015

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