BEUDAMED
    FDA Enforcement Class II Ongoing

    Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

    Recall: Z-1458-2022 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1458-2022
    Event ID
    90478
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 3, 2022
    Initiation Date
    May 18, 2022
    Classification Date
    July 25, 2022
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062, United States

    Description

    Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

    Reason

    Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

    Code Info

    Lot # : HN2204123455; UDI/DI: 00889795053329

    Distribution

    International distribution in the country of UK.

    Quantity

    3 units