BEUDAMED
    FDA Enforcement Class II Terminated

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    Recall: Z-2100-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2100-2018
    Event ID
    80012
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    VGI Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    April 9, 2018
    Classification Date
    June 5, 2018
    Termination Date
    August 21, 2020
    Address
    10401 Belcher Rd S, N/A, Seminole, FL, 33777-1415, United States

    Description

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    Reason

    IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated

    Code Info

    Lots of Instrument Sets: LP-INSTSET-001, VLP-INSTSET-002, VLP-INSTSET-003, VLP-INSTSET-004, VLP-INSTSET-005, VLP-INSTSET-006. Lots of individual instruments contained in sets: 127617, 127901, 127902, 127903, 127904, 127905, 127906, 127907, 127908, 133003, 133004, 133005, 1330-1, 1330-2, 1330-6, 133004, 1285001, 144301, 144302, 163214, 1401001, 157801, 162402 163203, 163204, 163205, 163206, 163207, 163208, 163209, 163212, 163213, and 163214.

    Distribution

    Distributed to MI, FL, and NY.

    Quantity

    6 units