BEUDAMED
    FDA Recall Open, Classified

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

    Recall: Z-2926-2020 · Initiated August 10, 2020

    Recall

    Recall Number
    Z-2926-2020
    Event Number
    86261
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    HSN
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    August 10, 2020
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

    Reason

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

    Action

    On August 18, 2020 Exactech sent an Urgent Product Recall Notice to all its consignees with the following instructions: -Immediately cease distribution or use of this product. -Extend this information to your accounts that may have this product in their possession. - Identify and quarantine any of the subject devices in your inventory (including loaner kits). -Complete and returned the attached Recall Inventory Response Form to Exactech via email at [email protected].

    Distribution

    Domestic: CO,FL,OK, PA. International: Chile

    Quantity

    11 units