Nakanishi Inc. 700 Shimohinata Kanuma Japan Recalls
Showing 1-2 of 2 recalls
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
On 7/3/2018, the recalling firm, NSK, initiated sending "URGENT: MEDICAL DEVICE RECALL- CORRECTION" notification letters, via email and mail, by YUSEN Logistics. The recalling firm reports that the initial importers were given the responsibility for sub-recalls to their customers and to extend to the wholesaler, the retailer, and the end user (medical user). Customers were informed to Locate the operation manuals associated with your SGS/SGA Surgical Handpiece; Dispose of the any of the following previous operation manuals associated with those handpieces you may have and replace them with new operation manuals enclosed in this mail; Be sure to reprocess your SGS/SGA handpieces before their next use according to the reprocessing instructions listed in the new operation manual. Complete the enclosed Correction Activity Sheet for Users so we can ensure that you have the most up-to-date reprocessing instructions. Please send the Correction Activity Sheet via e-mail, fax, or mail to: Technical Supervisor Service Division NSK America, Corp., 1800 Global Parkway, Hoffman Estates, IL 60192 US Fax: +1-800-838-9328, e-mail: NSKQA@NSKDental.com. Public (domestic distributors and their end users) are encouraged to call 1-888-675-1675 Ext. 203 and import-to export distributors are encouraged to call +81-3-5828-7816.
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).
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.
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.