BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0794-2019 · Initiated November 16, 2018

    Recall

    Recall Number
    Z-0794-2019
    Event Number
    81782
    Firm
    Ascension Orthopedics, Inc
    FEI Number
    3002788818
    Product Code
    HSD
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    November 16, 2018
    Terminated
    November 22, 2019
    Address
    8700 Cameron Rd, Ste 100, Austin, TX, 78754-3947

    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).

    Action

    On 11/16/18, the recalling firm sent out an Urgent Voluntary Medical Device Correction letter via email to affected customers to notify them of the product issue. A second, updated letter was sent on 12/13/18. The firm requests that all recipients please examine their inventory to determine if they have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691. Customers: - If you do have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please discard the First Choice DRUJ System Partial Ulnar Head Implant instructions packaged with the product and use the attached correct IFU provided to you along with this communication letter. Distributors: - If you do have any unused MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please return them to Integra. - We also kindly ask you to provide us the final customer list who may have the affected products. Integra will provide them the correct IFU. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 1- 609-936-5400; email: [email protected]

    Distribution

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