BEUDAMED
    FDA Enforcement Class II Ongoing

    Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

    Recall: Z-0871-2026 · Reported December 10, 2025

    Enforcement

    Recall Number
    Z-0871-2026
    Event ID
    97891
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2025
    Initiation Date
    October 13, 2025
    Classification Date
    December 2, 2025
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062, United States

    Description

    Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

    Reason

    Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

    Code Info

    UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030

    Distribution

    US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.

    Quantity

    20