BEUDAMED
    FDA Recall Open, Classified

    Lamicel 20PK 3MM INTL Cervical dilator

    Recall: Z-0733-2020 · Initiated November 13, 2019

    Recall

    Recall Number
    Z-0733-2020
    Event Number
    84332
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    LOB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 13, 2019
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    Lamicel 20PK 3MM INTL Cervical dilator

    Reason

    Routine sterilization dose does not meet the required Sterility Assurance Level.

    Action

    Medtronic will send the Consignee Notification and Customer Confirmation Form (or equivalent record) to each listed consignee. Consignees will be asked to confirm receipt of FCA notification.

    Distribution

    Affected product was only distributed in Japan.

    Quantity

    29320 units