BEUDAMED
    FDA Enforcement Class II Terminated

    OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.

    Recall: Z-1768-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1768-2021
    Event ID
    87661
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zavation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    March 25, 2021
    Classification Date
    June 1, 2021
    Termination Date
    March 20, 2023
    Address
    220 Lakeland Pkwy, Flowood, MS, 39232-9552, United States

    Description

    OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.

    Reason

    Products distributed as sterile may not have been adequately sterilized

    Code Info

    Lot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV

    Distribution

    US nationwide distribution.

    Quantity

    846 units