BEUDAMED
    FDA Enforcement Class II Ongoing

    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

    Recall: Z-2456-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2456-2026
    Event ID
    98629
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    March 16, 2026
    Classification Date
    June 16, 2026
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

    Reason

    Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.

    Code Info

    UDI-DI: 03596010514394. Lot/Batch: 25BM03616

    Distribution

    International distribution to the countries of BE, DE, IT.

    Quantity

    5