FDA recall Z-0221-2019

Nakanishi Inc. · Class II · device

Product

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 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

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

Key facts

Status
Terminated
Initiation date
2018-06-01
Report date
2018-10-31
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kanuma, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0221-2019