BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2456-2026 · Initiated March 16, 2026

    Recall

    Recall Number
    Z-2456-2026
    Event Number
    98629
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HSB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 16, 2026
    Posted
    June 16, 2026
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    On 3/16/2026, recall notices were emailed to customers who were asked to do the following: 1) Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this Field Action and provide to them a copy of this letter. 3. Please complete the Customer Response form and email or fax it to your national Smith+Nephew agency/distributor. 4. Return quarantined product to your national Smith+Nephew agency/distributor. 5. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. Firm contact information: + 1 901 396 2121, 1 800 821 5700

    Distribution

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

    Quantity

    5