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U.S. Department of Health and Human Services

Class 2 Device Recall Micro Surgery Handpiece

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  Class 2 Device Recall Micro Surgery Handpiece see related information
Date Initiated by Firm June 01, 2018
Date Posted October 24, 2018
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0224-2019
Recall Event ID 80713
510(K)Number K171155  
Product Classification Handpiece, rotary bone cutting - Product Code KMW
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..
Code Information Previous Operation Manuals:OM-SH0015E002, OM-SH0015E003,OM-SH0015E004, OM-SH0015E005, OM-SH0100F,OM-SH0096S.  Model Name: SGS-E2S; Order Code H266 Serial Nos.:0LZ00004 -0LZ00013, 0LZ00015- 0LZ00018, 0LZ00021 - 0LZ00030, 0LZ00036 - 0LZ00040, 0LZ00043- 0LZ00054 ; 0BB30001-0BB30010, 0BB30012 - 0BB30015; 0LZ00058; 0BB30022 - 0BB30026; 0BB50001-0BB50013, 0BB50021 - 0BB50025; 0BB70003 - 0BB70015; 0BB90007-0BB90027; 0BBX0001 - 0BBX0010; 0BBY0001 - 0BBY0027,  0BBY0031 - 0BBY0035; 0BBZ0017 - 0BBZ0026, 0BBZ0035 - 0BBZ0050; 0BC30001 - 0BC30004; 0BBZ0002 - 0BBZ0008; 0BC30008 - 0BC30020; 0BC50001 - 0BC50010; 0BC60001- 0BC60004, 0BC60006 - 0BC60031, 0BC60036 - 0BC60050;  0BC70001 - 0BC70015; 0BC90006 - 0BC90025, 0BC90031 -  0BC90050, 0BC90054 -0BC90060 - 0BC90080; 0BCX0001-0BCX0023; 0BCY0003 - 0BCY0027; 0BD10012 - 0BD10020;  0BD30001- 0BD30003, 0BD30006, 0BD30010- 0BD30018, 0BD10021 - 0BD10030; 0BD30028- 0BD30037; 0BD60021 - 0BD60030; 0BD60004 - 0BD60020, 0BD60031 - 0BD60033,  0BD60048 - 0BD60050; 0BD80001 - 0BD80017, 0BD80023 - 0BD80042, 0BBX0011, 0BBX0013, 0BBX0016 - 18, 0BBX0020; 0BD80047 - 0BD80050; ABDZ0001 - ABDZ0020; ABDZ0071 - ABDZ0080; ABDZ0027- ABDZ0070, ABDZ0081- ABDZ0086; ABE10023 - ABE10062; ABE 20008- ABE20026, ABE20028, ABE20036-ABE20055, ABE20065 - ABE20100; ABE50001 - ABE50004, ABE50019-ABE50058, ABE50080 - ABE50100; ABE90010 - ABE90050; ABEY0001-ABEY0012;  ABEY0033- ABEY0052, ABEY0081- ABEY0100; ABF40001 -  ABF40010, ABF40039- ABF40068, ABF40073 -ABF40092; ABF50020 - ABF50034; ABF60001 - ABF60015; ABFX0001 -  ABFX0030, ABFX0042- ABFX0050; ABFY0001 , ABFY0013 - ABFY0052; ABFZ0049 - ABFZ0050; ABG20001 - ABG20018, ABG20026 - ABG20030; ABG30019-ABG30038; ABG60084 -ABG60113; ABG80003 - ABG80015; ABG80026- ABG80035; ABG80056-ABG80062; ABG60153- ABG60161; ABG80001, ABG80016- ABG80025; ABG80036 - ABG80055; ABG80066 - ABG80085, ABG80110- ABG80115;  ABG90001 - ABG90019; ABG90038 - ABG90040; ABGX0001-ABGX0017, ABGX0029, ABGX0030, ABGZ0001- ABGZ0010; ABGZ0022 -ABGZ0051, ABGZ0055-ABGZ0060; ABH10001 - ABH10014; ABH20003 - ABH20030; ABH30001, ABH30002; ABH40032- ABH40035; ABH50001 -ABH50073; ABH60001-ABH60143; ABH60156- ABH60200; ABH70001-ABH70005, ABH70022 - ABH70051; ABH80002-ABH80032.                                                                                                                                                                                                                 -                                         ;          
Recalling Firm/
Manufacturer		 Nakanishi Inc.
700
Shimohinata
Kanuma Japan
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On 7/3/2018, the recalling firm, NSK, initiated sending "URGENT: MEDICAL DEVICE RECALL- CORRECTION" notification letters, via email and mail, by YUSEN Logistics. The recalling firm reports that the initial importers were given the responsibility for sub-recalls to their customers and to extend to the wholesaler, the retailer, and the end user (medical user). Customers were informed to Locate the operation manuals associated with your SGS/SGA Surgical Handpiece; Dispose of the any of the following previous operation manuals associated with those handpieces you may have and replace them with new operation manuals enclosed in this mail; Be sure to reprocess your SGS/SGA handpieces before their next use according to the reprocessing instructions listed in the new operation manual. Complete the enclosed Correction Activity Sheet for Users so we can ensure that you have the most up-to-date reprocessing instructions. Please send the Correction Activity Sheet via e-mail, fax, or mail to: Technical Supervisor Service Division NSK America, Corp., 1800 Global Parkway, Hoffman Estates, IL 60192 US Fax: +1-800-838-9328, e-mail: NSKQA@NSKDental.com. Public (domestic distributors and their end users) are encouraged to call 1-888-675-1675 Ext. 203 and import-to export distributors are encouraged to call +81-3-5828-7816.
Quantity in Commerce 1662
Distribution U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KMW and Original Applicant = Nakanishi Inc.
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