BEUDAMED
    FDA Enforcement Class II Terminated

    Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.

    Recall: Z-1140-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1140-2021
    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

    Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 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) 89-9194.07, Lot Numbers; 47782581 exp 5/1/2021 b) 89-9194.09, Lot Numbers: 50224694 exp 9/1/2023, 50326092 exp 9/1/2023, 50582301 exp 9/1/2023, 50795307 exp 11/1/2023, 51008862 exp 11/1/2023, 51153103 exp 11/1/2023 c) 89-9194-10, Lot Numbers: 51434221 exp 11/1/2023, 51881522 exp 11/1/2023 d) 89-9194-11, Lot Numbers: 52175785 exp 8/1/2022, 52849153 exp 11/1/2023, 53220664 exp 2/1/2025, 53327306 exp 2/1/2025, 53409521 exp 9/1/2023, 53565355 exp 12/1/2024

    Distribution

    Distributors in OK, MI, and TX.

    Quantity

    776 packs