BEUDAMED
    FDA Recall Terminated

    Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.

    Recall: Z-0200-2018 · Initiated May 16, 2017

    Recall

    Recall Number
    Z-0200-2018
    Event Number
    77479
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    HSN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 16, 2017
    Terminated
    April 22, 2021
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.

    Reason

    Possible inner labeling and packaged device not matching the outer label on the box.

    Action

    Customers were notified via letter dated May 16, 2017. Instructions included to immediately cease distribution of the affected products, identify and quarantine any devices in inventory, complete and return the Recall Inventory Response Form, notify customers if further distributed. For further questions, please call (352) 377-1140.

    Distribution

    Distributed in North Carolina

    Quantity

    9