Neocis Guidance System Fiducial Array Recall: Failed Landmark Check Risk
Neocis recalls Fiducial Array units with serial numbers FA-0128-02, FA-0129-02, FA0130-02 due to potential failed landmark checks during dental implant surgery. Affected users should contact Neocis for guidance.
Lower-risk recall
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Contact the company
What happened, in plain English
Neocis is recalling specific Fiducial Array units used in dental implant surgery because they may cause failed landmark checks. This could lead to incorrect surgical planning and potential complications during procedures. Read more at govinfonow.com/recall/66898-neocis-guidance-system-fiducial-array-recall-failed-landmark-check-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66898-neocis-guidance-system-fiducial-array-recall-failed-landmark-check-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0511-2020
Cite this page
“Neocis Guidance System Fiducial Array Recall: Failed Landmark Check Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66898-neocis-guidance-system-fiducial-array-recall-failed-landmark-check-risk. Based on FDA recall #Z-0511-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0511-2020%22&limit=1).
Why it’s dangerous
The Fiducial Array contains metal beads that serve as markers for the computerized navigational system. If these markers mismatch the measurement files, the system may fail to correctly check landmarks during surgery, potentially leading to incorrect implant placement.
Who’s affected
Dental surgeons and clinics using the Neocis Guidance System with the recalled Fiducial Array units (serial numbers FA-0128-02, FA-0129-02, FA0130-02) are most at risk.
How to tell if you have this one
Check if your Neocis Guidance System Fiducial Array has serial numbers FA-0128-02, FA-0129-02, or FA0130-02. These units were sold with the system for dental implant procedures.
- Brand
Neocis- Category
Medical device
What to do — step by step
Contact Neocis
Reach out to Neocis for guidance on next steps regarding the recalled Fiducial Array units.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
FDA distribution: “US Nationwide distribution in the states of AR, OK, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, New York, Oklahoma.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0511-2020 (October 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0511-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.