BEUDAMED
    FDA Enforcement Class II Completed

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.

    Recall: Z-2502-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2502-2020
    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 L30, H7mm, Part #018.1907.

    Reason

    Reports received of the device fracturing during insertion.

    Code Info

    Lot numbers 14LEDODB, 15CNDOGC, and 15DJDOEC .

    Distribution

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

    Quantity

    39 units