Home / Recalls / Medical Devices
Nakanishi Inc. recalls Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for
Recalled October 31, 2018 · FDA recall Z-0219-2019 · Nakanishi
Hazard
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. · FDA Class II
Units
12
Sold at
U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Description
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.
Product
Surgical Handpiece, Model: SGS-E, Order Code: H084, 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(s)
Nakanishi Inc.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →