FDA Device recall Z-0224-2019
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended…
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended… 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-0224-2019 |
| 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 SGS, Model: SGS-E2S, Order Code: H266, 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. Model N…Previous Operation Manuals:OM-SH0015E002, OM-SH0015E003,OM-SH0015E004, OM-SH0015E005, OM-SH0100F,OM-SH0096S. Model Name: SGS-E2S; Order Code H266 Serial Nos.:0LZ00004 -0LZ00013, 0LZ00015- 0LZ00018, 0LZ00021 - 0LZ00030, 0LZ00036 - 0LZ00040, 0LZ00043- 0LZ00054 ; 0BB30001-0BB30010, 0BB30012 - 0BB30015; 0LZ00058; 0BB30022 - 0BB30026; 0BB50001-0BB50013, 0BB50021 - 0BB50025; 0BB70003 - 0BB70015; 0BB90007-0BB90027; 0BBX0001 - 0BBX0010; 0BBY0001 - 0BBY0027, 0BBY0031 - 0BBY0035; 0BBZ0017 - 0BBZ0026, 0BBZ0035 - 0BBZ0050; 0BC30001 - 0BC30004; 0BBZ0002 - 0BBZ0008; 0BC30008 - 0BC30020; 0BC50001 - 0BC50010; 0BC60001- 0BC60004, 0BC60006 - 0BC60031, 0BC60036 - 0BC60050; 0BC70001 - 0BC70015; 0BC90006 - 0BC90025, 0BC90031 - 0BC90050, 0BC90054 -0BC90060 - 0BC90080; 0BCX0001-0BCX0023; 0BCY0003 - 0BCY0027; 0BD10012 - 0BD10020; 0BD30001- 0BD30003, 0BD30006, 0BD30010- 0BD30018, 0BD10021 - 0BD10030; 0BD30028- 0BD30037; 0BD60021 - 0BD60030; 0BD60004 - 0BD60020, 0BD60031 - 0BD60033, 0BD60048 - 0 |
|---|
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-0224-2019%22
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