medical Class II Updated 2018-10-31

Nakanishi Inc. recalls Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanis

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Affected States: CA, FL, GA, IL, WA

Lot/Code Info: Model Name: SGS-E2G Order Code: H185 *Note: There were no shipments of SGS-E2G between 2011 and April 2018 to the U.S. Market.

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