BEUDAMED
    FDA Enforcement Class II Ongoing

    BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

    Recall: Z-0212-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0212-2026
    Event ID
    97670
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    October 29, 2025
    Initiation Date
    September 23, 2025
    Classification Date
    October 17, 2025
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

    Reason

    There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

    Code Info

    UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666

    Distribution

    Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA 2025-00166_Initial Distribution History containing the distribution and the identification of the domestic consignees.

    Quantity

    98 units