BEUDAMED
    FDA Enforcement Class II Terminated

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    Recall: Z-0202-2015 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0202-2015
    Event ID
    69493
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 19, 2014
    Initiation Date
    September 22, 2014
    Classification Date
    November 12, 2014
    Termination Date
    May 7, 2015
    Address
    1552 W Carroll Ave, Chicago, IL, 60607-1012, United States

    Description

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    Reason

    Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

    Code Info

    Model Number: 02.07.10.0162

    Distribution

    Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.

    Quantity

    1 rod (US); 145 rods (global)