BEUDAMED
    FDA Enforcement Class II Ongoing

    Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

    Recall: Z-1337-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1337-2018
    Event ID
    79548
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Gyrus ACMI, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    August 3, 2017
    Classification Date
    April 10, 2018
    Address
    2925 Appling Rd, Bartlett, TN, 38133-3901, United States

    Description

    Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

    Reason

    "Chattering" when cutting burrs are used in bone.

    Code Info

    Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

    Distribution

    NM, MI, and TX EU, Australia, Japan, and Hong Kong

    Quantity

    324