BEUDAMED
    FDA Recall Terminated

    DeRoyal Tonsillectomy Tray, REF 89-10698.01

    Recall: Z-0906-2023 · Initiated November 28, 2022

    Recall

    Recall Number
    Z-0906-2023
    Event Number
    91287
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 28, 2022
    Posted
    January 5, 2023
    Terminated
    March 18, 2026
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    Description

    DeRoyal Tonsillectomy Tray, REF 89-10698.01

    Reason

    DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

    Action

    DeRoyal issued an URGENT! DEROYAL RECALL NOTICE on 11/28/2022 to the distributor by email and to the end used by overnight USPS. The notice explained the problem and requested the following actions be taken: 1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or [email protected] no later than December 15, 2022. 3) If you have questions regarding credit for the recall, please contact Jennifer Marsh at [email protected] or by phone 865-362-4203 or email us at [email protected]. 4) PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) If you have further distributed these products, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer list and we will contact them.

    Distribution

    Distribution in US states of VA, and SC.

    Quantity

    320 units