FDA recall Z-0226-2019

Product

Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: 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-0226-2019