Reported Nov 27, 2019 · Terminated

Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational…

Neocis Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Neocis Inc. · 2800 Biscayne Blvd Ste 600 · Miami, FL · 33137-4523

Is this the product you have?

  • Neocis Guidance
  • System Fiducial Array - Product UsageThe 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
Lot codes and dates
  • Serial Numbers
    • FA-0128-02
    • FA-0129-02
    • FA0130-02
Amount recalled
3 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 5, 2020 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.