Z-0511-2020Class II

Neocis Guidance System Fiducial Array -

Name: Z-0511-2020 Neocis Guidance System Fiducial Array -
Creator: Neocis Inc.
Published: 2019-10-04
License: https://open.fda.gov/license/

Neocis Inc. / initiated 2019-10-04 / Terminated / root cause: manufacturing process

FDA source

Neocis Inc. began a recall of Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in... on 2019-10-04. FDA classified it as Class II and gives the reason as "The Fiducial Array may mismatch their measurement files resulting in failed landmark check". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0511-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-04
Posted: 2019-11-21
Terminated: 2020-10-05
Recalling firm: Neocis Inc.
Product: 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.
Product code: PLV Dental Stereotaxic Instrument
Reason for recall: The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of AR, OK, NY.
Product codes and lots: Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0511-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0511-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21

Product code PLV

K161399Class IINeocis Guidance SystemNeocis, Inc. / cleared 2016-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)