BEUDAMED
    FDA Enforcement Class II Terminated

    "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.

    Recall: Z-0122-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0122-2013
    Event ID
    63081
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthosensor
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 31, 2012
    Initiation Date
    February 4, 2012
    Classification Date
    October 24, 2012
    Termination Date
    December 12, 2012
    Address
    1560 Sawgrass Corporate Pkwy, 4th Floor, Sunrise, FL, 33323-2858, United States

    Description

    "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.

    Reason

    Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the Link station was obstructed by OR metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru

    Code Info

    Version 1.82

    Distribution

    Nationwide Distribution including the states of CA, FL, MI and NY.

    Quantity

    9