Reported Oct 31, 2018 · Terminated
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical…
Nakanishi Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nakanishi Inc. · 700 · Kanuma, N/A · N/A
Is this the product you have?
- Micro Surgery Handpiece SGA, Model SGA-ES
- Order CodeH263
- Manufactured byNakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical
- usage includes dental implant usedrilling and tapping the maxilla and mandible
- Lot codes and dates
- Previous Operation Manuals
OM-SH0015E002OM-SH0015E003OM-SH0015E004OM-SH0015E005OM-SH0100FOM-SH0096S
- Model NameSGA-ES
- Order Code
70 of 70 codes
H263 0BB10068 - 0BB100690BB20006 -0BB200100BB30044-0BB300460BB30051 - 0BB300530BB60035 - 0BB600420BB700210BB700220BB700250BB700260BB60063 - 0BB600720BB700200BB700230BB700240BBX0042 - 0BBX00440BC10046 - 0BC100700BC20053 - 0BC200600BC30011 - 0BC300140BC30081 -0BC300870BC40041- 0BC400430BC40054 -0BC400630BC50009- 0BC500180BC50041-0BC500440BC50046- 0BC500550BC500650BC500660BC500730BC500740BC60010- 0BC600190BC90031 - 0BC900350BCY0086 - 0BCY00950BD50003 -0BD50012ABDZ0011 -ABDZ0020ABDZ0083-ABDZ0102ABDZ0112-ABDZ0117ABE30001-ABE30015ABE30017- ABE30034ABE40069 - ABE40088ABE40095ABE40096ABE50001- ABE50010ABE50012- ABE50021ABE40090ABE50036 - ABE50040ABE90009 - ABE90018ABE90041 - ABE90050ABEY0001- ABEY0010ABF40022 - ABF40041ABF50031- ABF50040ABF70020 - ABF70025ABF70058 - ABF70065ABFY0021- ABFY0030ABFX0030ABFY0001 - ABFY0006ABFY0008-ABFY0010ABFZ0034- ABFZ0039ABFZ0041ABFZ0042ABFZ0044- ABFZ0053ABG40011-ABG40022ABG40024
- Previous Operation Manuals
- Amount recalled
- 440
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Nakanishi Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.