|
Class 2 Device Recall Micro Surgery Handpiece |
|
Date Initiated by Firm |
June 01, 2018 |
Date Posted |
October 24, 2018 |
Recall Status1 |
Terminated 3 on April 28, 2021 |
Recall Number |
Z-0223-2019 |
Recall Event ID |
80713 |
510(K)Number |
K171155
|
Product Classification |
Handpiece, rotary bone cutting - Product Code KMW
|
Product |
Micro Surgery Handpiece SGS, Model: SGS-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. |
Code Information |
Previous Operation Manuals: OM-SH0015E002,OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S Model Name: SGS-ES; Order Code H264/H264007 Serial Nos.:0LZ00063 - 0LZ00064, 0LZ00066 - 0LZ00068, 0LZ00070 - 0LZ00109; 0LZ00110 - 0LZ00115; 0BB20112 -0BB20116, 0BB20226 - 0BB20229, 0BB40071 - 0BB40075, 0BB50186 - 0BB50189, 0BB50215 - 0BB50224, 0BB50263, 0BB50265, 0BB50266, 0BB50185, 0BB50190 - 0BB50192; 0BB60051 - 0BB60055, 0BB60079 - 0BB60100, 0BB60106 -0BB60118, 0BB70066 - 0BB70100, 0BB90004 - 0BB90058, 0BB90123 - 0BB90132, 0BBX0168 - 0BBX0175;0BBY0188 -0BBY0192; 0BC10095 - 0BC10099, 0BC10101 - 0BC10110, 0BC10121 - 0BC10130, 0BC10169 - 0BC10170, 0BC10176- 0BC10179, 0BC50093 - 0BC50102, 0BC60001 - 0BC60040, 0BC60085 - 0BC60104, 0BC60078 - 0BC60081, 0BC90001 - 0BC90090; 0BCY0003 - 0BCY0032; 0BD40011 -0BD40020, 0BD60001 - 0BD60034, 0BD60008 - 0BD60010, 0BD60016, 0BD60142-0BD60150, 0BD70062-0BD70072, 0BD80001 -0BD80034, 0BD80095 - 0BD80100, 0BDX0021 -0BDX0040, 0BDX0084- 0BDX0093; 0BDY0001- 0BDY0068, ABE10092 - ABE10121, ABE30001 - ABE30068, ABE30079 - ABE30088, ABE 60001- ABE60068, ABE 60056-ABE60065, ABE60005, ABE60011-ABE60015, ABE60030, ABE60136 - ABE60145, ABE70051- ABE70056, ABE90099-ABE90100; ABEX0001- ABEX0008; ABEY0052 - ABEY0071, ABEX0141 - ABEX0149; ABEY0011 - ABEY0020, ABEY0051; ABF10011- ABF10030, ABF20050, ABF20071 - ABF20079, ABF30014 - ABF30033, ABF70161 - ABF70166; ABFX0046 - ABFX0051, ABFX0053, ABFX0063, ABFY0031 -ABFY0033, ABFY0038- ABFY0040, ABFZ0043-ABFZ0062, ABFY0121 - ABFY0130; ABFZ0001 - ABFZ0040;ABG60147- ABG60154, ABG60156, ABG60159 - ABG60166; ABG70011- ABG70018, ABG70039 - ABG70048, ABG70059 -ABG70090; ABH50001 - ABH50009, ABH50010- ABH50400; ABH40106 - ABH40115; ABH60128 - ABH60137; ABH70001 - ABH70505; ABH80329- ABH80338; ABHX0001 - ABHX0343 - ; |
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 |
2419 |
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.
|
|
|
|