BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0012-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0012-2019
    Event ID
    80996
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 10, 2018
    Initiation Date
    August 21, 2018
    Classification Date
    October 2, 2018
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States

    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.

    Code Info

    Serial Numbers: 5214432, 5214445

    Distribution

    In the countries of Australia and France

    Quantity

    2 units