Reported Oct 31, 2018 · Terminated
Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for…
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?
- Surgical Handpiece
- ModelSGS-E2G
- Order CodeH185, Nakanishi 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
- Model NameSGS-E2G
- Order CodeH185 *Note: There were no shipments of SGS-E2G between 2011 and April 2018 to the U.S. Market
- Amount recalled
- 0
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.
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