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U.S. Department of Health and Human Services

Class 2 Device Recall NEODENT CM Intraoral Scanbody

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  Class 2 Device Recall NEODENT CM Intraoral Scanbody see related information
Date Initiated by Firm March 13, 2017
Date Posted April 07, 2017
Recall Status1 Terminated 3 on February 28, 2019
Recall Number Z-1831-2017
Recall Event ID 76843
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product NEODENT CM Intraoral Scanbody, Article Number: 108.139
Code Information Lot Numbers: 800.214.016, 800.217.067, 56.390, 63.224, 71.065, 71.066, 71.067, 71.068, 71.069, and 71.070.
Recalling Firm/
Manufacturer		 Instradent USA, Inc.
60 Minuteman Rd
Andover MA 01810-1008
Manufacturer Reason
for Recall		 During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
FDA Determined
Cause 2		 Component design/selection
Action Instradent sent an Urgent Field Safety Notice dated March 13, 2017, to all affected customers via UPS. Customers were asked to take the following actions: 1. Identify and segregate the affected units from your stock. 2. If the product is still in your Inventory, return it for credit. 3. If you have used the product successfully, there is no need to take any action 4. For all cases complete and return the enclosed Customer Confirmation Form. For further questions, please call (855) 412-8883.
Quantity in Commerce 170 pieces
Distribution Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
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.
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