Class 2 Device Recall Ultradent Products, Inc. Paper Points

• Date Initiated by Firm: August 04, 2017
• Create Date: September 26, 2017
• Recall Status: Terminated on January 04, 2018
• Recall Number: Z-3215-2017
• Recall Event ID: 77891
• Product Classification: Point, paper, endodontic - Product Code EKN
• Product: Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. ; ; Product Usage:; The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
• Code Information: Lot numbers BD96Z, BDTDM, and BDTQ6
• Recalling Firm/ Manufacturer: Ultradent Products, Inc.; 505 W 10200 S; South Jordan UT 84095-3800
• For Additional Information Contact: Karen Kakunes; 801-553-4366
• Manufacturer Reason for Recall: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
• FDA Determined Cause: Process change control
• Action: The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.
• Quantity in Commerce: 95 units
• Distribution: Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
• 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.