BEUDAMED
    FDA Enforcement Class II Ongoing

    PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

    Recall: Z-2555-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2555-2025
    Event ID
    97265
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Orthofix U.S. LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2025
    Initiation Date
    June 24, 2025
    Classification Date
    September 11, 2025
    Address
    3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States

    Description

    PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

    Reason

    A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

    Code Info

    UDI-DI: 18257200161010, Lots: 001, 002, and 003

    Distribution

    US Nationwide distribution in the states of CO, CA.

    Quantity

    3