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U.S. Department of Health and Human Services

Class 2 Device Recall NanoTips

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  Class 2 Device Recall NanoTips see related information
Date Initiated by Firm December 14, 2016
Date Posted January 17, 2017
Recall Status1 Terminated 3 on June 05, 2017
Recall Number Z-1034-2017
Recall Event ID 76039
Product Classification Syringe, restorative and impression material - Product Code EID
Product NanoTips 30g 20pk, 100pk PN 1240, 1426
Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT¿ plus, UltraSeal XT¿ hydro, Ultra-Etch¿, PermaFloIdeal for microscopic restorative dentistry
Code Information Lot Numbers: BD6KM, BCVPG, BCTBY, BD3K4, BCWVZ
Recalling Firm/
Manufacturer		 Ultradent Products, Inc.
505 W 10200 S
South Jordan UT 84095-3800
For Additional Information Contact Benjamin Bailey
801-553-4858
Manufacturer Reason
for Recall		 Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
FDA Determined
Cause 2		 Device Design
Action Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated December 14, 2016, to all affected consignees. The letter instructed consignees to discard remaining inventory and return the response form. For any questions, please call at 801-553-4858.
Quantity in Commerce 143 packs of 100 tips; 104 packs of 20 tips
Distribution Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.
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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