BEUDAMED
    FDA Enforcement Class II Ongoing

    Medshape Universal Joints, REF: DNE-9000-UJ

    Recall: Z-2513-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2513-2025
    Event ID
    97064
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medshape, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 10, 2025
    Initiation Date
    June 2, 2025
    Classification Date
    September 3, 2025
    Address
    1575 Northside Dr Nw Ste 440, N/A, Atlanta, GA, 30318-4211, United States

    Description

    Medshape Universal Joints, REF: DNE-9000-UJ

    Reason

    Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

    Code Info

    UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921

    Distribution

    US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA.

    Quantity

    849