Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0224-2019 — Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, 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..

U.S. FDA — Device Enforcement · Japan · 2018-06-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0224-2019
Date of alert: 2018-06-01
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: Nakanishi Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0224-2019 — Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, 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..

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