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.
FDA Recall Z-0511-2020 · Posted None
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Recalling FirmNeocis Inc.
Recall StatusTerminated
Product CodePLV
Date Initiated2019-10-04
Date Terminated2020-10-05
Product Quantity3 units
Reason for Recall
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of AR, OK, NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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