Z-0219-2019Class II

Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are...

Name: Z-0219-2019 Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are...
Creator: Nakanishi Inc.
Published: 2018-06-01
License: https://open.fda.gov/license/

Nakanishi Inc. / initiated 2018-06-01 / Terminated / root cause: design

FDA source

Nakanishi Inc. began a recall of Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental... on 2018-06-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0219-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-01
Posted: 2018-10-24
Terminated: 2021-04-28
Recalling firm: Nakanishi Inc.
Product: 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.
Product code: KMW Handpiece, Rotary Bone Cutting
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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: [email protected]. 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.
Quantity in commerce: 12
Distribution: U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Product codes and lots: Previous Operation Manual: OM-H0035E001 Model Name: SGS-E Order Code: H084, Serial Nos. FL400001 - FL400005; FL500008 - FL500010; FL400012-FL400015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0219-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0219-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0220-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0221-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0222-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0223-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0224-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0225-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0226-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code KMW

K171155Class IISurgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. / cleared 2017-11-21

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)