BEUDAMED
    FDA Enforcement Class II Completed

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

    Recall: Z-2503-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2503-2020
    Event ID
    85218
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    CTL Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 15, 2020
    Initiation Date
    August 21, 2019
    Classification Date
    July 4, 2020
    Address
    4550 Excel Pkwy Ste 300, Addison, TX, 75001-5714, United States

    Description

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

    Reason

    Reports received of the device fracturing during insertion.

    Code Info

    Lot numbers 14LEDOAB, 15CNDOCC, 15DIDOBC, and 7FGBD.

    Distribution

    Distribution was made to AZ, FL, IN, KS, MA, MI, NY, TN, and TX.

    Quantity

    45 units