Recall Z-1034-2017
Ultradent Products, Inc. · initiated December 14, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Numbers: BD6KM, BCVPG, BCTBY, BD3K4, BCWVZ
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1034-2017
- Initiated
- December 14, 2016
- Posted by FDA
- January 17, 2017
- Terminated
- June 5, 2017
- Product code
- EID – Syringe, Restorative And Impression Material
- Quantity
- 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.
- Recalling firm
- Ultradent Products, Inc., South Jordan, UT