BEUDAMED
    FDA Enforcement Class II Terminated

    Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10

    Recall: Z-2024-2021 · Reported July 14, 2021

    Enforcement

    Recall Number
    Z-2024-2021
    Event ID
    88165
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vivorte, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 14, 2021
    Initiation Date
    September 9, 2018
    Classification Date
    July 7, 2021
    Termination Date
    November 17, 2021
    Address
    1044 E Chestnut St, Louisville, KY, 40204-6033, United States

    Description

    Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10

    Reason

    incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 12-18-2018

    Code Info

    Lot Number: MA-170727-01 Donation Identification Number (DIN): W2292 14 141647 00 Serial Numbers: 093 through 105. Human readable UDI (under QR code on label): =/W4146EB0010T0475=W22921414164700=,000XXX=>019046=}017239&,100000000MA17072701 where XXX ranges from 093 through 105.

    Distribution

    US state of KY

    Quantity

    12 units