BEUDAMED
    FDA Enforcement Class II Terminated

    OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.

    Recall: Z-0398-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0398-2018
    Event ID
    78901
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    September 29, 2017
    Classification Date
    January 19, 2018
    Termination Date
    July 30, 2019
    Address
    4500 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.

    Reason

    This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.

    Code Info

    Catalog ID: 532.021 VET Serial #: 190673

    Distribution

    Internationally to Canada

    Quantity

    1