BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0871-2026 · Initiated October 13, 2025

    Recall

    Recall Number
    Z-0871-2026
    Event Number
    97891
    Firm
    Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062
    FEI Number
    3008650117
    Product Code
    HSB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 13, 2025
    Posted
    December 2, 2025

    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.

    Action

    On 10/13/2025, recall notices were emailed to distributors who were asked to do the following: 1) Return affected devices to the firm using return label. 2) Ensure that in instances where you have distributed this affected product, that you forward this Recall Notification to your customers. 3) Replacements are available by contacting [email protected] Complaints can be directed to [email protected]

    Distribution

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

    Quantity

    20