BEUDAMED
    FDA Enforcement Class II Terminated

    InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.

    Recall: Z-1755-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1755-2021
    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

    InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.

    Reason

    Products distributed as sterile may not have been adequately sterilized

    Code Info

    a) INTVMN-10-DSK, Lot Numbers: 12200ZV b) INTVMN-15-DSK, Lot Numbers: 10816ZV, 13708ZV, 13845ZV, 13522ZV, 12133ZV c) INTVMN-15-DSKC, Lot Numbers: 11843ZV, 11412ZV, 11160ZV, 11017ZV d) INTVMN-20-DSK, Lot Numbers: 14266ZV, 14238ZV, 12524ZV, 11756ZV, 11083ZV

    Distribution

    US nationwide distribution.

    Quantity

    119 units