BEUDAMED
    FDA Enforcement Class II Ongoing

    Lamicel 20PK 3MM INTL Cervical dilator

    Recall: Z-0733-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0733-2020
    Event ID
    84332
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Xomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    November 13, 2019
    Classification Date
    December 23, 2019
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218, United States

    Description

    Lamicel 20PK 3MM INTL Cervical dilator

    Reason

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

    Code Info

    UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438

    Distribution

    Affected product was only distributed in Japan.

    Quantity

    29320 units