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-0128-02FA-0129-02FA0130-02
- Serial Numbers
- 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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