BEUDAMED
    FDA Enforcement Class II Ongoing

    Hintermann Series Talar Implant, Left, Size 2 REF 302112

    Recall: Z-2399-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2399-2026
    Event ID
    98987
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DT MedTech, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2026
    Initiation Date
    March 24, 2026
    Classification Date
    June 10, 2026
    Address
    111 Moffitt St, N/A, Mcminnville, TN, 37110-2235, United States

    Description

    Hintermann Series Talar Implant, Left, Size 2 REF 302112

    Reason

    Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

    Code Info

    Lot: AACAA/ DI: B095302112

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.

    Quantity

    67 units