BEUDAMED
    FDA Enforcement Class II Terminated

    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

    Recall: Z-2086-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2086-2014
    Event ID
    68341
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    March 7, 2014
    Classification Date
    July 21, 2014
    Termination Date
    August 4, 2014
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States

    Description

    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

    Reason

    The femoral stem is lacking specified plasma coating.

    Code Info

    Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252

    Distribution

    Worldwide Distribution including Spain, Greece and Japan

    Quantity

    10