Z-0220-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- June 1, 2018
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
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.
Reason for Recall
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.
Distribution Pattern
U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Code Information
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.