FDA Device recall Z-0226-2019
Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: 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 previ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0226-2019 |
| 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
Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: 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 Manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S. Mode…Previous Operation Manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S. Model name: SGA-E2S Order Code: H265 ABB10001-ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023- ABB20044, ABB30001- ABB30015, ABB30021-ABB30053, ABB40001-ABB40012, ABB40023-ABB40025, ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60041-ABB60050, ABB60052-ABB60054, ALZ00064-ALZ00073;ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023-ABB20044;ABB30001-ABB30015,ABB30021-ABB30053;ABB40001-ABB40012, ABB40023-ABB40025;ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60018-ABB60025, ABB60026-ABB60050, ABB60052-ABB60068, ABB60075-ABB60101; ABB90001-ABB90017, ABB90023-ABB90032, ABB90034-ABB90050, ABBX0001-ABBX0008, ABBX0011-ABBX0025, ABBX0032-ABBX0046;ABBZ0009-ABBZ0023;ABBY0012, ABBY0015-ABBY0018, ABBY0041-ABBY0050; ABBZ0029-ABBZ0050; ABC20001-ABC20008, ABC20024-ABC20050;ABC30001-ABC30043, ABC30049-ABC30050; ABC50001-ABC50010; ABC60001-ABC60043, ABC60053-AB |
|---|
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-0226-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.