BEUDAMED
    FDA Recall Open, Classified

    For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

    Recall: Z-2518-2023 · Initiated July 20, 2023

    Recall

    Recall Number
    Z-2518-2023
    Event Number
    92813
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    GWG
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    July 20, 2023
    Posted
    September 6, 2023
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

    Reason

    Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the visual field is obscured.

    Action

    Aesculap issued Urgent Medical Device Recall Notification Letter via USPS Certified Mail 20.JUL.2023. Letter states reason for recall, health risk and action to take: 1. Review the Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Your Aesculap Sales Representative will be in contact with you to review your current inventory, aid in evaluating your devices and assist you in completing the attached Product Acknowledgement Form. 3. Do not destroy any affected product. 4. Utilizing the attached form, you and your Sales Representative will record the total number of individual impacted pieces. If you have no inventory remaining, a zero (0) will be entered on the form. 5. Return the completed "Product Acknowledgement Form" to Aesculap, Inc. Product Quality Excellence department by emailing the form to [email protected] or faxing the form to (610) 849-1197 after your inventory has been evaluated by your Sales Representative, even if the total inventory in your possession is zero (0). 6. Once Aesculap, Inc. receives your "Product Acknowledgement Form", a customer support representative will contact you with instructions on how to return any impacted pieces in your possession.

    Distribution

    US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.

    Quantity

    25 units