BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02

    Recall: Z-0707-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0707-2023
    Event ID
    91134
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 21, 2022
    Initiation Date
    November 3, 2022
    Classification Date
    December 15, 2022
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02

    Reason

    XXX

    Code Info

    Lot Numbers: 56169083 exp 12/01/2023; 56357092 exp 12/01/2023; 56481018 exp 12/01/2023; 56538205 exp 09/01/2023; 56873265 exp 09/01/2023; 56895966 exp 09/01/2023; 56942611 exp 03/01/2024; 57088584 exp 03/01/2024; 57088592 exp 03/01/2024; 57180516 exp 03/01/2024; 57270562 exp 03/01/2024; 57313163 exp 03/01/2024; 57313171 exp 03/01/2024; 57492608 exp 03/01/2024; 57646152 exp 03/01/2024; 57681329 exp 03/01/2024; 57717598 exp 03/01/2024; 57788708 exp 03/01/2024; 57889681 exp 03/01/2024; 57928563 exp 03/01/2024; 57960070 exp 03/01/2024; 58003845 exp 04/01/2024; 58032523 exp 04/01/2024

    Distribution

    US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

    Quantity

    336 kits