Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions
Nakanishi Inc. is recalling SGS-E2G surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure to update documentation and reprocessing instructions, which aligns with the rubric for minor labeling or documentation issues.
Plain-English summary
Nakanishi Inc. is recalling the SGS-E2G Surgical Handpiece (Order Code: H185) to replace previous operation manuals with updated reprocessing instructions. The new instructions provide specific parameters for manual cleaning and autoclave sterilization.
The recalled handpieces are intended for surgical use, including dental implant drilling and tapping. The distribution included the U.S. states of California, Florida, Georgia, Illinois, and Washington, as well as Canada. There were no shipments of the SGS-E2G model to the U.S. market between 2011 and April 2018.
Users of these devices should replace their existing operation manuals with the new ones containing the updated reprocessing instructions.
The recalled product
- Product
- Surgical Handpiece, Model: SGS-E2G Order Code: H185, 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.
- Manufacturer
- Nakanishi Inc.
- Hazard
Distribution
Part of a larger recall action
This product is one of 8 recalled by Nakanishi Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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