Recall Z-2672-2016 · ELC Scaler, Ultrasonic

Nakanishi Inc.

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, i

Date	Jul 8, 2016
Status	Terminated
Reason	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 Nakanish
Root 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 compl
Quantity	30719 units
Distribution	Nationwide Distribution to Illinois, Florida and Georgia.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K031421

ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
Nakanishi, Inc., Mar 26, 2004