Nakanishi Inc.: Medical Device Recall in 2018 - (Recall #: Z-0219-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 1, 2018

Date Posted: October 31, 2018

Recall Number: Z-0219-2019

Event ID: 80713

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.

Status: Terminated

Product Quantity: 12

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.

Voluntary or Mandated:

Voluntary: Firm initiated