Nakanishi Inc. recalls Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for su…

Recall date

June 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0222-2019

FDA classification

Class II

Brand / firm

Nakanishi Inc.

Sold / distributed

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Surgical Handpiece, Model: SGA-E2G Order Code: H184, 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.