Class 2 Device Recall Nakanishi Inc.

• Date Initiated by Firm: July 08, 2016
• Create Date: August 26, 2016
• Recall Status: Terminated on June 25, 2018
• Recall Number: Z-2672-2016
• Recall Event ID: 74666
• 510(K)Number: K031421
• Product Classification: Scaler, ultrasonic - Product Code ELC
• Product: Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). ; The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
• Code Information: Waiting for clarification from the firm.
• Recalling Firm/ Manufacturer: Nakanishi Inc.; 700; Shimohinata; Kanuma Japan
• For Additional Information Contact: Jeff Dickens,; 847-843-7664
• Manufacturer Reason for Recall: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.
• FDA Determined Cause: Error in labeling
• Action: Naknishi sent out an URGENT : MEDICAL DEVICE CORRECTION letter on July 18, 2016 describing the potential safety issue regarding their Diamond Coated Products. The firm is requesting customers take the following actions: 1. Examine their inventory immediately to determine if they have any product, both used and unused, bearing any of the Nakanishi Product Codes listed in List of Products enclosed with this letter. 2. Immediately dispose of any USED product according to applicable regulations. 3. Segregate any UNUSED product for return to Nakanishi. 4. In order for the firm to complete their records, they are requesting that customers complete the enclosed Correction Activity Sheet and FAX or Mail to: NSK America, Corp. 1800 Global Parkway, Hoffman Estates, IL 60192 US Facsimile: 1-800-838-9328 Customers with questions were advised to Telephone: 1-888-675-1675. NSKrecall@NSKDental.com For questions regarding this recall call 847-843-7664.
• Quantity in Commerce: 30719 units
• Distribution: Nationwide Distribution to Illinois, Florida and Georgia.
• 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.

• 510(K) Database: 510(K)s with Product Code = ELC and Original Applicant = NAKANISHI, INC.