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U.S. Department of Health and Human Services

Class 2 Device Recall Neocis Guidance System

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  Class 2 Device Recall Neocis Guidance System see related information
Date Initiated by Firm October 30, 2020
Create Date January 26, 2021
Recall Status1 Terminated 3 on August 11, 2021
Recall Number Z-0929-2021
Recall Event ID 87060
510(K)Number K173402  
Product Classification Dental stereotaxic instrument - Product Code PLV
Product DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Code Information Work Order (Lot) Number 1573
Recalling Firm/
Manufacturer		 Neocis, Inc.
530 NW 29th St
Miami FL 33127-3917
For Additional Information Contact Dr. Alon Mozes, PhD
786-483-7490
Manufacturer Reason
for Recall		 The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter on 10/30/2020 via UPS overnight delivery. The letter explains the issue, refers to the original recall and requests that the consignee set aside any affected product. Neocis Field Personnel will inspect the devices and return them to the manufacturing facility.
Quantity in Commerce 100 units
Distribution OH, FL, CT, MA, AZ PA, 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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