BEUDAMED
    FDA Enforcement Class II Terminated

    Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

    Recall: Z-1030-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1030-2017
    Event ID
    75989
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    November 7, 2016
    Classification Date
    January 17, 2017
    Termination Date
    August 5, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States

    Description

    Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

    Reason

    Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

    Code Info

    Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086

    Distribution

    AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.

    Quantity

    79 units