BEUDAMED
    FDA Enforcement Class II Ongoing

    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis

    Recall: Z-0419-2026 · Reported November 12, 2025

    Enforcement

    Recall Number
    Z-0419-2026
    Event ID
    97765
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2025
    Initiation Date
    September 26, 2025
    Classification Date
    November 3, 2025
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis

    Reason

    Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.

    Code Info

    UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480

    Distribution

    US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS

    Quantity

    63 units