BEUDAMED
    FDA Enforcement Class II Terminated

    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    Recall: Z-0623-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0623-2018
    Event ID
    79092
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    September 1, 2017
    Classification Date
    February 15, 2018
    Termination Date
    April 3, 2019
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    Reason

    The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).

    Code Info

    ELAN 4 Air System ST0607 ELAN 4 Air Control Set ST0608 ELAN 4 Air Neuro Crani Set ST0609 ELAN 4 Air Spine Set ST06411 ELAN 4 Air HD Spine Set ST0614 ELAN 4 Air Micro Saw Set ST0615 ELAN 4 Air Hand Control Set ST0638 ELAN 4 Air Large Saw Set

    Distribution

    Nationwide Distribution.

    Quantity

    167 Units