Recall Z-0226-2019— Nakanishi Inc.
Class II · Terminated
Class II FDA medical device recall by Nakanishi Inc., initiated 2018-06-01, terminated 2021-04-28. It names one FDA 510(k) clearance: K171155. 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.. Reason: 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..
- Recalling firm
- Nakanishi Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-01
- Terminated
- 2021-04-28
- Firm location
- Kanuma, N/A, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.