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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84070

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 04, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Neocis Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0511-2020
Recall number
Z-0511-2020
Initiated
October 04, 2019
Classification
Class II
Status
Terminated
Recalling firm
Neocis Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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