BEUDAMED
    FDA Enforcement Class III Terminated

    Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW

    Recall: Z-0794-2019 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0794-2019
    Event ID
    81782
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ascension Orthopedics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 13, 2019
    Initiation Date
    November 16, 2018
    Classification Date
    February 1, 2019
    Termination Date
    November 22, 2019
    Address
    8700 Cameron Rd Ste 100, Austin, TX, 78754-3947, United States

    Description

    Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW

    Reason

    The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).

    Code Info

    170691

    Distribution

    Distributed to accounts in MO. Foreign distribution to Korea and Thailand.