Neocis Guidance System Fiducial Array Recalled for Measurement Mismatch
Neocis Inc. is recalling three units of the Neocis Guidance System Fiducial Array because they may mismatch measurement files, resulting in a failed landmark check.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Neocis Inc. is recalling three units of the Neocis Guidance System Fiducial Array. The affected units are identified by serial numbers FA-0128-02, FA-0129-02, and FA0130-02. These products were distributed in the United States in the states of Arkansas, Oklahoma, and New York.
The recall was initiated because the Fiducial Array may mismatch their measurement files, resulting in a failed landmark check. The Neocis Guidance System 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 Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.
The agency has classified this recall as Class II. Users should contact Neocis Inc. for further instructions regarding the affected units.
The recalled product
- 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…
- Manufacturer
- Neocis Inc.
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial Numbers: FA-0128-02
- FA-0129-02
- FA0130-02
Distribution
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