FDA Device recall Z-0220-2019
Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc by Nakanishi, citing reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0220-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-01 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nakanishi |
| Distribution | CA, FL, GA, IL, WA |
Product
Surgical Handpiece, Model: SGS-E2G Order Code: H185, 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.
Reason
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.
Identifiers
| code_info | Model Name: SGS-E2G Order Code: H185 *Note: There were no shipments of SGS-E2G between 2011 and April 2018 to the U.S. Market. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0220-2019%22
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