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U.S. Department of Health and Human Services

Class 2 Device Recall Neocis Guidance System (NGS)

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 Class 2 Device Recall Neocis Guidance System (NGS)see related information
Date Initiated by FirmMay 14, 2020
Create DateJuly 16, 2020
Recall Status1 Terminated 3 on July 27, 2021
Recall NumberZ-2637-2020
Recall Event ID 85856
510(K)NumberK173402 
Product Classification Dental stereotaxic instrument - Product Code PLV
ProductDRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Code Information Work Order (lot): 1619 and 1620
Recalling Firm/
Manufacturer		 Neocis Inc.
2800 Biscayne Blvd Ste 600
Miami FL 33137-4523
For Additional Information ContactDr. Alon Mozes, PhD
305-409-2819
Manufacturer Reason
for Recall		The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
FDA Determined
Cause 2		Process control
ActionCustomers were notified via UPS overnight mail sent 05/19/2020. Notification also included a site visit from the Neocis Clinical Sales Representative or Neocis Field Clinical Engineer. Customers are asked to stop use of the Gen II Posterior Splints until a trained person from Neocis has inspected their inventory. 100% effectiveness checks are planned.
Quantity in Commerce70 units
DistributionUS Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = PLV
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