BEUDAMED
    FDA Enforcement Class II Terminated

    HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE

    Recall: Z-0677-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0677-2019
    Event ID
    81641
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    November 15, 2018
    Classification Date
    December 22, 2018
    Termination Date
    June 18, 2020
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611, United States

    Description

    HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE

    Reason

    Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

    Code Info

    UDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570

    Distribution

    CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV