medical Class II Updated 2018-10-31

Nakanishi Inc. recalls Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanis

Recalled Product

Surgical Handpiece, Model: SGA-E Order Code: H083, 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: Previous Operation Manual: OM-H0035E001 Model Name: SGA-E, Order Code: H083 FL800010-FL800020; FLY00001-FLY00007.
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