BEUDAMED
    FDA Enforcement Class II Ongoing

    Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

    Recall: Z-1256-2024 · Reported March 13, 2024

    Enforcement

    Recall Number
    Z-1256-2024
    Event ID
    93900
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 13, 2024
    Initiation Date
    December 21, 2023
    Classification Date
    March 5, 2024
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062, United States

    Description

    Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

    Reason

    Medical devices distributed, prior to sterilization

    Code Info

    PA23006856

    Distribution

    US:CA OUS: None

    Quantity

    1