Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for sur
FDA device recall Z-0220-2019 · posted 2018-10-24 · Terminated
Recall details
- Recalling firm
- Nakanishi Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KMW
- Quantity affected
- 0
- Distribution
- U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
- Date initiated
- 2018-06-01
- Date posted
- 2018-10-24
- Date terminated
- 2021-04-28
- Location
- Kanuma, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Surgical Angle Handpiece, Surgical Straight Handpiece (K171155) | Nakanishi, Inc. | 2017-11-21 |