BEUDAMED
    FDA Enforcement Class II Terminated

    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

    Recall: Z-1823-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1823-2020
    Event ID
    84989
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    U&I CORP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 6, 2020
    Initiation Date
    January 30, 2019
    Classification Date
    April 29, 2020
    Termination Date
    November 20, 2020
    Address
    20 Sandan-Ro 76 Beon-Gil, N/A, Uijeongbu-Si Gyeonggi-Do, N/A, N/A, Korea (the Republic of)

    Description

    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

    Reason

    The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.

    Code Info

    Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    42