Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc ...
FDA Device Recall #Z-0224-2019 — Class II — June 1, 2018
Recall Summary
| Recall Number | Z-0224-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 1, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nakanishi Inc. |
| Location | Kanuma, N/A |
| Product Type | Devices |
| Quantity | 1662 |
Product Description
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 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.
Distribution Pattern
U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Lot / Code Information
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 - 0BD60050; 0BD80001 - 0BD80017, 0BD80023 - 0BD80042, 0BBX0011, 0BBX0013, 0BBX0016 - 18, 0BBX0020; 0BD80047 - 0BD80050; ABDZ0001 - ABDZ0020; ABDZ0071 - ABDZ0080; ABDZ0027- ABDZ0070, ABDZ0081- ABDZ0086; ABE10023 - ABE10062; ABE 20008- ABE20026, ABE20028, ABE20036-ABE20055, ABE20065 - ABE20100; ABE50001 - ABE50004, ABE50019-ABE50058, ABE50080 - ABE50100; ABE90010 - ABE90050; ABEY0001-ABEY0012; ABEY0033- ABEY0052, ABEY0081- ABEY0100; ABF40001 - ABF40010, ABF40039- ABF40068, ABF40073 -ABF40092; ABF50020 - ABF50034; ABF60001 - ABF60015; ABFX0001 - ABFX0030, ABFX0042- ABFX0050; ABFY0001 , ABFY0013 - ABFY0052; ABFZ0049 - ABFZ0050; ABG20001 - ABG20018, ABG20026 - ABG20030; ABG30019-ABG30038; ABG60084 -ABG60113; ABG80003 - ABG80015; ABG80026- ABG80035; ABG80056-ABG80062; ABG60153- ABG60161; ABG80001, ABG80016- ABG80025; ABG80036 - ABG80055; ABG80066 - ABG80085, ABG80110- ABG80115; ABG90001 - ABG90019; ABG90038 - ABG90040; ABGX0001-ABGX0017, ABGX0029, ABGX0030, ABGZ0001- ABGZ0010; ABGZ0022 -ABGZ0051, ABGZ0055-ABGZ0060; ABH10001 - ABH10014; ABH20003 - ABH20030; ABH30001, ABH30002; ABH40032- ABH40035; ABH50001 -ABH50073; ABH60001-ABH60143; ABH60156- ABH60200; ABH70001-ABH70005, ABH70022 - ABH70051; ABH80002-ABH80032. - ;
Other Recalls from Nakanishi Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0219-2019 | Class II | Surgical Handpiece, Model: SGS-E, Order Code: H... | Jun 1, 2018 |
| Z-0221-2019 | Class II | Surgical Handpiece, Model: SGA-E Order Code: ... | Jun 1, 2018 |
| Z-0225-2019 | Class II | Micro Surgery Handpiece SGA, Model SGA-ES, Ord... | Jun 1, 2018 |
| Z-0223-2019 | Class II | Micro Surgery Handpiece SGS, Model: SGS-ES, Ord... | Jun 1, 2018 |
| Z-0222-2019 | Class II | Surgical Handpiece, Model: SGA-E2G Order Code... | Jun 1, 2018 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.