BEUDAMED
    FDA Recall 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 · Initiated September 1, 2017

    Recall

    Recall Number
    Z-0623-2018
    Event Number
    79092
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    September 1, 2017
    Posted
    February 15, 2018
    Terminated
    April 3, 2019
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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).

    Action

    On September 1, 2017 an Urgent Medical Device Recall letter was issued to customers for the ELAN 4 Air System which includes the following sub-components: 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 The letter directs customers to take the following actions: 1. Review the Voluntary Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use. 2. Determine your current inventory of affected products within your facility. Immediately remove the affected products and return to Aesculap Inc. Do not destroy any affected products. 3. Utilizing the attached Product Recall Acknowledgement Response Form on the next page of this letter, record the total number of products in your possession. If you have no inventory remaining, please enter zero (0) on the form and a REASON WHY (example, returned evaluation system to sales representative). 4. Please contact Customer Service and they will provide you with a Returned Goods number and return label. Customer Service: 1-800-282-9000 [email protected]

    Distribution

    Nationwide Distribution.

    Quantity

    167 Units