BEUDAMED
    FDA Enforcement Class III Ongoing

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    Recall: Z-0736-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0736-2023
    Event ID
    91147
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2022
    Initiation Date
    November 7, 2022
    Classification Date
    December 20, 2022
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    Reason

    Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

    Code Info

    UDI# P/N 6191-0-001 (01)07613327128772 (17)261031(10)lot# GTIN: 07613327128772 -Instructions for Use (IFU) received with product: 0700-7-010 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, with Exp. Date on/after September 16, 2021.

    Distribution

    International distribution in the country of Turkey.

    Quantity

    2085 units