BEUDAMED
    FDA Recall Open, Classified

    DEXLOCK Achilles Repair Implant Kits, MAKT4520

    Recall: Z-0911-2026 · Initiated November 11, 2025

    Recall

    Recall Number
    Z-0911-2026
    Event Number
    98056
    FEI Number
    1417592
    Product Code
    NWN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 11, 2025
    Posted
    December 11, 2025
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    DEXLOCK Achilles Repair Implant Kits, MAKT4520

    Reason

    There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

    Action

    Firm began notifying consignees on 11/11/2025 via Urgent Medical Device Recall letters. Customers have been instructed to over-label kits with a sticker instructing them to not use the drill guide within the Achilles Kit and to use the reusable 3.6mm drill guide from the Soft Tissue Instrument Tray. Customers who do not have a Soft Tissue Instrument Tray have been instructed to notify Medline so that a tray can be provided. Customers were instructed to quarantine all affected product in stock and return a completed response form to Medline. Upon receipt of the response form, the firm will then provide over-labels to place on affected inventory. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI.

    Quantity

    163 US