# FDA recall Z-0221-2019

> **Nakanishi Inc.** · Class II · device recall initiated 2018-06-01.

## 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

- **Recall number:** Z-0221-2019
- **Recalling firm:** Nakanishi Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0221-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0221-2019. Source: US FDA. Licensed CC0.

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