BEUDAMED
    FDA Enforcement Class II Terminated

    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.

    Recall: Z-2127-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2127-2016
    Event ID
    74317
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    May 26, 2016
    Classification Date
    July 5, 2016
    Termination Date
    July 26, 2019
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.

    Reason

    Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.

    Code Info

    Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021.

    Distribution

    Nationwide Distribuiton to OK, ME, NY, & Hawaii.

    Quantity

    8 units