BEUDAMED
    FDA Enforcement Class II Terminated

    Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.

    Recall: Z-1139-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1139-2021
    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

    Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 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) 89-7483.07, Lot Numbers: 48535952 exp 3/1/2021, 48613789 exp 3/1/2021, 49330297 exp 7/1/2021, 49529669 exp 8/1/2021, 49852263 exp 9/1/2021 b) 89-7483.08, Lot Numbers: 50033361 exp 11/1/2021, 50404628 exp 12/1/2021, 50783200 exp 12/1/2021 c) 89-7483.09, Lot Numbers: 51021872 exp 12/1/2021, 51121460 exp 4/1/2022, 51284373 exp 4/30/2022, 51458898 exp 4/1/2022, 51701317 exp 7/1/2022 d) 89-7483.10, Lot Numbers: 51954402 exp 9/1/2022, 52183224 exp 9/1/2022, 52413069 exp 10/1/2022, 53117579 exp 10/1/2022, 53311005 exp 11/1/2022

    Distribution

    Distributors in OK, MI, and TX.

    Quantity

    1084 packs