BEUDAMED
    FDA Recall Completed

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.

    Recall: Z-2504-2020 · Initiated August 21, 2019

    Recall

    Recall Number
    Z-2504-2020
    Event Number
    85218
    Firm
    CTL Medical Corporation
    FEI Number
    3009051471
    Product Code
    MAX
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    August 21, 2019
    Address
    4550 Excel Pkwy, Ste 300, Addison, TX, 75001-5714

    Description

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.

    Reason

    Reports received of the device fracturing during insertion.

    Action

    The recalling firm issued letters dated 8/21/2019 to all distributors or CTL representatives via email beginning 8/21/2019 with a follow-up hard copy of the correspondence being issued via FedEx. The devices were to be returned.

    Distribution

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

    Quantity

    46 units