FDA (Devices) recall action 80713

Nakanishi Inc. recalled 8 products on 2018-10-31

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2018-10-31
Critical: 0
Units: 6,435

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

ModerateFDA (Devices)··2018-10-31
Nakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions
Nakanishi Inc. is recalling six SGA-E2G surgical handpieces because reprocessing instructions have been updated to include manual cleaning and specific autoclave parameters.
Product
Surgical Handpiece, Model: SGA-E2G Order Code: H184, 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.
Category
Distribution
5 states
ModerateFDA (Devices)··2018-10-31
Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions
Nakanishi Inc. is recalling SGS-E2G surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.
Product
Surgical Handpiece, Model: SGS-E2G Order Code: H185, 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.
Category
Distribution
5 states
ModerateFDA (Devices)··2018-10-31
Nakanishi SGS-ES Micro Surgery Handpiece Recall for Updated Instructions
Nakanishi Inc. is recalling 2,419 SGS-ES Micro Surgery Handpieces to replace operation manuals with updated reprocessing and sterilization instructions.
Product
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, 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.
Category
Distribution
5 states
ModerateFDA (Devices)··2018-10-31
Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions
Nakanishi Inc. is recalling 1,878 Micro Surgery Handpiece SGA units to replace operation manuals with updated reprocessing and sterilization instructions.
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.
Category
Distribution
5 states
ModerateFDA (Devices)··2018-10-31
Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions
Nakanishi Inc. is recalling 440 Micro Surgery Handpiece SGA units because reprocessing instructions have been updated. Previous operation manuals must be replaced.
Product
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, 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.
Category
Distribution
5 states
ModerateFDA (Devices)··2018-10-31
Nakanishi SGA-E Surgical Handpieces Recalled for Updated Reprocessing Instructions
Nakanishi Inc. is recalling 18 SGA-E surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave sterilization parameters.
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.
Category
Distribution
5 states
ModerateFDA (Devices)··2018-10-31
Nakanishi SGS Surgical Handpieces Recalled for Updated Reprocessing Instructions
Nakanishi Inc. is recalling 1,662 SGS-E2S surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave parameters.
Product
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..
Category
Distribution
5 states
ModerateFDA (Devices)··2018-10-31
Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions
Nakanishi Inc. is recalling 12 SGS-E surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.
Product
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.
Category
Distribution
5 states