BEUDAMED
    FDA Enforcement Class II Terminated

    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

    Recall: Z-2262-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2262-2015
    Event ID
    71663
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    June 24, 2015
    Classification Date
    July 27, 2015
    Termination Date
    June 24, 2016
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

    Reason

    The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.

    Code Info

    Lot 53839799 and 414012

    Distribution

    US Distribution to TX and GA.

    Quantity

    10 units