BEUDAMED
    FDA Enforcement Class II Terminated

    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

    Recall: Z-0603-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0603-2018
    Event ID
    78064
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    July 11, 2017
    Classification Date
    February 13, 2018
    Termination Date
    April 22, 2021
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States

    Description

    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

    Reason

    Vix Bit may fracture during use.

    Code Info

    Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001

    Distribution

    Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.

    Quantity

    41 devices