BEUDAMED
    FDA Recall Open, Classified

    Medshape Universal Joints, REF: DNE-9000-UJ

    Recall: Z-2513-2025 · Initiated June 2, 2025

    Recall

    Recall Number
    Z-2513-2025
    Event Number
    97064
    Firm
    Medshape, INC.
    FEI Number
    3007593722
    Product Code
    KTT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 2, 2025
    Posted
    September 3, 2025
    Address
    1575 Northside Dr Nw, Ste 440, Atlanta, GA, 30318-4211

    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.

    Action

    On 6/2/2025, recall notice were emailed to consignees who were asked to do the following: 1) Review your stock for the products and lot numbers for the items to be returned. 2) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3) Complete acknowledgement and response form and return via email to [email protected] If you have any questions, contact firm at [email protected]

    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