BEUDAMED
    FDA Enforcement Class III Terminated

    Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

    Recall: Z-0546-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0546-2020
    Event ID
    84219
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    SPINEART SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 4, 2019
    Initiation Date
    February 5, 2019
    Classification Date
    November 22, 2019
    Termination Date
    April 28, 2021
    Address
    Chemin Du Pre-Fleuri 3, Plan-Les-Ouates, N/A, Switzerland

    Description

    Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

    Reason

    Inner blister pack label is incorrect and does not match the correct external box label.

    Code Info

    Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899

    Distribution

    US: CA OUS: Unknowns

    Quantity

    14 pieces distribtued to 1 US Distributor