BEUDAMED
    FDA Recall Open, Classified

    Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

    Recall: Z-3130-2024 · Initiated July 5, 2024

    Recall

    Recall Number
    Z-3130-2024
    Event Number
    95162
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    EQJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 5, 2024
    Posted
    September 12, 2024
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

    Reason

    Product was distributed past expiration date.

    Action

    Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its sole consignee on 07/05/2024 via in person visit. The notice explained the problem, potential risk if used, and requested the product be quarantined.

    Distribution

    International distribution to the country of Canada.

    Quantity

    1 unit