BEUDAMED
    FDA Recall Open, Classified

    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail

    Recall: Z-2443-2023 · Initiated July 24, 2023

    Recall

    Recall Number
    Z-2443-2023
    Event Number
    92767
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HSB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 24, 2023
    Posted
    August 22, 2023
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail

    Reason

    A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

    Action

    Smith & Nephew issued an Urgent Medical Device Recall Notice on 07/24/2023. The notice explained the problem with the product, the potential risk, and requested the consignees locate and quarantine the affected product for return. Sales reps, district offices, or distributors were directed to notify their customers and ensure that the required actions were complete. The firm is seeking return of the affected product.

    Distribution

    US, AE, CA, DE, ES, GB, MX, PA, PL

    Quantity

    30 units