BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1677-2023
    Event ID
    92210
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2023
    Initiation Date
    April 13, 2023
    Classification Date
    June 2, 2023
    Address
    249 Vanderbilt Ave, Norwood, MA, 02062-5033, United States

    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

    Code Info

    UDI-DI:10886705002108 All lot numbers

    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