BEUDAMED
    FDA Enforcement Class II Ongoing

    GS0008 2Y - Burn Pack - STL, Item Number 880082025

    Recall: Z-0070-2024 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-0070-2024
    Event ID
    93077
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 11, 2023
    Initiation Date
    September 11, 2023
    Classification Date
    October 5, 2023
    Address
    3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States

    Description

    GS0008 2Y - Burn Pack - STL, Item Number 880082025

    Reason

    Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.

    Code Info

    UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16

    Distribution

    Missouri

    Quantity

    103 kits