BEUDAMED
    FDA Enforcement Class II Ongoing

    Lamicel 10PK 10MM INTL

    Recall: Z-0735-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0735-2020
    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 10PK 10MM INTL

    Reason

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

    Code Info

    UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170

    Distribution

    Affected product was only distributed in Japan.

    Quantity

    10 packs; 100 units