BEUDAMED
    FDA Recall Open, Classified

    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724

    Recall: Z-1677-2023 · Initiated April 13, 2023

    Recall

    Recall Number
    Z-1677-2023
    Event Number
    92210
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    MAI
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    April 13, 2023
    Posted
    June 2, 2023
    Address
    249 Vanderbilt Ave, Norwood, MA, 02062-5033

    Description

    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724

    Reason

    IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

    Action

    DePuy Mitek issued Urgent Medical Device Correction (Notification) Letter on 4/13/23 via First Class Mail to US consignees. Internal and sales/distributors notified via email. International affiliates will be notified via email and will be initiated per local regulations. Letter states reason for recall, health risk and action to take: 1. Product is NOT being removed from the field and does not need to be returned. 2. Familiarize yourself with the content 2. Familiarize yourself with the content of this letter. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to [email protected] within three (3) business days of receipt of this notification. IMPORTANT: Complete the BRF even if you do not have any of the subject product in your current inventory. 4. Forward this notice to any personnel in your facility who need to be informed. 5. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand.

    Quantity

    805 units