FDAFDA · Food and drugs·Recall number Z-0221-2019
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.
Published October 31, 2018 · Recall initiated: June 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nakanishi Inc.
- Distributor
- U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
- Lot
- Previous Operation Manual: OM-H0035E001 Model Name: SGA-E, Order Code: H083 FL800010-FL800020; FLY00001-FLY00007.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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