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U.S. Department of Health and Human Services

Class 2 Device Recall Neocis Guidance System Fiducial Array

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  Class 2 Device Recall Neocis Guidance System Fiducial Array see related information
Date Initiated by Firm October 04, 2019
Create Date November 21, 2019
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-0511-2020
Recall Event ID 84070
510(K)Number K161399  
Product Classification Dental stereotaxic instrument - Product Code PLV
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.
Code Information Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02
Recalling Firm/
Manufacturer		 Neocis Inc.
2800 Biscayne Blvd Ste 600
Miami FL 33137-4523
For Additional Information Contact
305-409-2819
Manufacturer Reason
for Recall		 The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PLV and Original Applicant = Neocis Inc.
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