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Surgical Handpiece, Model: SGA-E Order Code: H083… recallZ-0221-2019 · Nakanishi Inc. · initiated Jun 1, 2018

Class II Terminated All recalls posted in October 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nakanishi Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0221-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 1, 2018
Posted by the FDA
Oct 24, 2018
Recalling firm
Nakanishi Inc.
Quantity
18
Product code
KMW
FDA submissions
K171155
Distribution
U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

Product description

Surgical Handpiece, Model: SGA-E Order Code: H083, 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.

Code information (models, lots, serial numbers)

Previous Operation Manual: OM-H0035E001  Model Name: SGA-E, Order Code: H083 FL800010-FL800020; FLY00001-FLY00007.

Other devices under the same FDA submission

2 devices cleared under K171155 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80713).

Sources and updates

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