BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0070-2024 · Initiated September 11, 2023

    Recall

    Recall Number
    Z-0070-2024
    Event Number
    93077
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    OJJ
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    September 11, 2023
    Posted
    October 6, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    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.

    Action

    ROi CPS, LLC issued a Medical Device Correction notice to its sole consignee on 09/11/2023 by email. The notice explained the issue with the Zimmer Dermatone Blade contained in the kit, the risk, and requested the consignee affix a sticker to the exterior of the kit requesting that the blade be removed and discarded at the time of use.

    Distribution

    Missouri

    Quantity

    103 kits