BEUDAMED
    FDA Recall Open, Classified

    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

    Recall: Z-0012-2019 · Initiated August 21, 2018

    Recall

    Recall Number
    Z-0012-2019
    Event Number
    80996
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    KWT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 21, 2018
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

    Reason

    The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

    Action

    The firm disseminated the field safety notice by email on 08/21/2018. The notice requested the following actions: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory " Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech.

    Distribution

    In the countries of Australia and France

    Quantity

    2 units