FDA Device recall Z-0219-2019
Surgical Handpiece, Model: SGS-E, Order Code: H084, 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-E, Order Code: H084, 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-0219-2019 |
| 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-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.
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 | Previous Operation Manual: OM-H0035E001 Model Name: SGS-E Order Code: H084, Serial Nos. FL400001 - FL400005; FL500008 - FL500010; FL400012-FL400015. |
|---|
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-0219-2019%22
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