BEUDAMED
    FDA Recall Terminated

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    Recall: Z-2100-2018 · Initiated April 9, 2018

    Recall

    Recall Number
    Z-2100-2018
    Event Number
    80012
    Firm
    VGI Medical, LLC
    FEI Number
    3006982954
    Product Code
    OVD
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 9, 2018
    Terminated
    August 21, 2020
    Address
    10401 Belcher Rd S, Seminole, FL, 33777-1415

    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

    Action

    The firm notified their direct consignees by letter on 04/09/2018 and followed with an e-mail on 04/11/2018. The letter directed the direct consignees (distributors) to instruct their accounts (user) to discontinue the automated cleaning process and to provide users with the new IFUs.

    Distribution

    Distributed to MI, FL, and NY.

    Quantity

    6 units