BEUDAMED
    FDA Recall Terminated

    Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.

    Recall: Z-0511-2020 · Initiated October 4, 2019

    Recall

    Recall Number
    Z-0511-2020
    Event Number
    84070
    Firm
    Neocis Inc.
    FEI Number
    3012787974
    Product Code
    PLV
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 4, 2019
    Terminated
    October 5, 2020
    Address
    2800 Biscayne Blvd, Ste 600, Miami, FL, 33137-4523

    Description

    Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.

    Reason

    The Fiducial Array may mismatch their measurement files resulting in failed landmark check.

    Action

    This firm initiated the recall by visit, field service personnel to each affected to customer to retrieve the nonconforming parts beginning on 10/04/2019. The firm followed this action officially notified customers, via letter on sent on October 15, 2019.

    Distribution

    US Nationwide distribution in the states of AR, OK, NY.

    Quantity

    3 units