BEUDAMED
    FDA Enforcement Class II Ongoing

    Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

    Recall: Z-1600-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1600-2026
    Event ID
    98341
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    I.T.S. GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2026
    Initiation Date
    January 23, 2026
    Classification Date
    March 20, 2026
    Address
    Autal 28, Lasnitzhohe, N/A, Austria

    Description

    Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

    Reason

    Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

    Code Info

    1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).

    Distribution

    US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

    Quantity

    11 units