BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1030-2017 · Initiated November 7, 2016

    Recall

    Recall Number
    Z-1030-2017
    Event Number
    75989
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 7, 2016
    Terminated
    August 5, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    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.

    Action

    In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at [email protected] or 1-800-392-2832.

    Distribution

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

    Quantity

    79 units