Device 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.
Z-0219-2019
Product summary
- Firm
- Nakanishi Inc.
- Event
- Event 80713
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-0219-2019
Official wording
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 information: Previous Operation Manual: OM-H0035E001 Model Name: SGS-E Order Code: H084, Serial Nos. FL400001 - FL400005; FL500008 - FL500010; FL400012-FL400015.
Distribution pattern: U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Derived failure modes
-
Unknown
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.