BEUDAMED
    FDA Enforcement Class II Ongoing

    HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

    Recall: Z-1468-2022 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1468-2022
    Event ID
    90436
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2022
    Initiation Date
    May 26, 2022
    Classification Date
    July 27, 2022
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062, United States

    Description

    HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

    Reason

    Due to Titanium plasma coating not present implant.

    Code Info

    Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202

    Distribution

    U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.

    Quantity

    9 implants