BEUDAMED
    FDA Enforcement Class II Terminated

    ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.

    Recall: Z-1764-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1764-2021
    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

    ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.

    Reason

    Products distributed as sterile may not have been adequately sterilized

    Code Info

    Lot Numbers: 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, 14016ZV

    Distribution

    US nationwide distribution.

    Quantity

    79 units