BEUDAMED
    FDA Enforcement Class II Terminated

    CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.

    Recall: Z-1138-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1138-2021
    Event ID
    87218
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 3, 2021
    Initiation Date
    January 25, 2021
    Classification Date
    February 19, 2021
    Termination Date
    July 21, 2022
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.

    Reason

    Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

    Code Info

    a) 89-7935.11, Lot codes: 48285959 exp 12/21/2022 b) 89-7935.12, Lot codes: 49057260 exp 5/1/2023, 49239952 exp 4/1/2023, 49481001 exp 6/1/2023, 49603726 exp 8/1/2023, 49864125 exp 7/1/2021 c) 89-7935.13, Lot codes: 50404644 exp 11/1/2021, 50698398 exp 11/1/2023 d) 89-7935.14, Lot codes: 5125317 exp 6/1/2022 e) 89-7935.15, Lot codes: 51305461 exp 2/1/2024, 51983318 exp 2/1/2024 f) 89-7935.16, Lot codes: 53324463 exp 12/1/2024

    Distribution

    Distributors in OK, MI, and TX.

    Quantity

    309 packs