{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "cfres_id": "166434",
      "product_res_number": "Z-0222-2019",
      "event_date_initiated": "2018-06-01",
      "event_date_posted": "2018-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-28",
      "res_event_number": "80713",
      "product_code": "KMW",
      "k_numbers": [
        "K171155"
      ],
      "product_description": "Surgical Handpiece,  Model: SGA-E2G  Order Code: H184, Nakanishi Inc.\n\n The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.",
      "code_info": "Previous Operation Manual: OM-H0035E001  Model Name: SGA-E2G Order Code: H184 Serial Nos. BL600026 - BL600031",
      "firm_fei_number": "3002807687",
      "recalling_firm": "Nakanishi Inc.",
      "address_1": "700",
      "city": "Kanuma",
      "country": "Japan",
      "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.",
      "root_cause_description": "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\nthe most up-to-date reprocessing instructions. Please send the Correction Activity Sheet via e-mail, fax, or mail to: Technical Supervisor Service Division\nNSK America, Corp., 1800 Global Parkway, Hoffman Estates, IL 60192 US\nFax: +1-800-838-9328, e-mail: NSKQA@NSKDental.com. \n\nPublic (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.",
      "product_quantity": "6",
      "distribution_pattern": "U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.",
      "openfda": {
        "k_number": [
          "K211584",
          "K970953",
          "K171155",
          "K080939",
          "K162544",
          "K862110",
          "K971692",
          "K994298",
          "K932255"
        ],
        "device_name": "Handpiece, Rotary Bone Cutting",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.4120",
        "device_class": "2",
        "registration_number": [
          "3014953747",
          "1649518",
          "3006540014",
          "3007279848",
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          "3010185635",
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          "3030126955",
          "2027754"
        ],
        "fei_number": [
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          "3001236277",
          "3006540014",
          "3007279848",
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        ]
      }
    }
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}