Z-2673-2016Class II

Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)...

Name: Z-2673-2016 Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)...
Creator: Nakanishi Inc.
Published: 2016-07-08
License: https://open.fda.gov/license/

Nakanishi Inc. / initiated 2016-07-08 / Terminated / root cause: labeling and UDI

FDA source

Nakanishi Inc. began a recall of Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the... on 2016-07-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2673-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-08
Posted: 2016-08-26
Terminated: 2018-06-25
Recalling firm: Nakanishi Inc.
Product: Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.
Product code: ELC Scaler, Ultrasonic
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.
Root cause tag: labeling and UDI
FDA 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 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. [email protected] For questions regarding this recall call 847-843-7664.
Quantity in commerce: 2574 units
Distribution: Nationwide Distribution to Illinois, Florida and Georgia.
Product codes and lots: Waiting for clarification from the firm.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2673-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2672-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26
Z-2673-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26
Z-2674-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26

Product code ELC

K073678Class IIVariosurgNakanishi, Inc. / cleared 2008-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)