BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0221-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0221-2019
    Event ID
    80713
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nakanishi Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    June 1, 2018
    Classification Date
    October 23, 2018
    Termination Date
    April 28, 2021
    Address
    700, Shimohinata, Kanuma, N/A, N/A, Japan

    Description

    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.

    Reason

    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.

    Code Info

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

    Distribution

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

    Quantity

    18