{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177120",
      "product_res_number": "Z-0511-2020",
      "event_date_initiated": "2019-10-04",
      "event_date_created": "2019-11-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-05",
      "res_event_number": "84070",
      "product_code": "PLV",
      "k_numbers": [
        "K161399"
      ],
      "product_description": "Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.",
      "code_info": "Serial Numbers:  FA-0128-02, FA-0129-02, FA0130-02",
      "firm_fei_number": "3012787974",
      "recalling_firm": "Neocis Inc.",
      "address_1": "2800 Biscayne Blvd Ste 600 2800 Biscayne Blvd",
      "address_2": "Ste 600",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33137-4523",
      "additional_info_contact": "305-409-2819",
      "reason_for_recall": "The Fiducial Array may mismatch their measurement files resulting in failed landmark check.",
      "root_cause_description": "Process control",
      "action": "This firm initiated the recall by visit, field service personnel to each affected to customer to retrieve the nonconforming parts beginning on 10/04/2019.  The firm followed this action officially notified customers, via letter on sent on October 15, 2019.",
      "product_quantity": "3 units",
      "distribution_pattern": "US Nationwide distribution in the states of AR, OK, NY.",
      "openfda": {
        "k_number": [
          "K203401",
          "K192579",
          "K161399",
          "K173402",
          "K251835",
          "K210947",
          "K200805",
          "K200662",
          "K191363",
          "K182776",
          "K150222",
          "K200348",
          "K161406",
          "K213392",
          "K191605",
          "K202100",
          "K211129",
          "K252376",
          "K231018",
          "K211466",
          "K233563",
          "K210711",
          "K202264"
        ],
        "registration_number": [
          "3012787974",
          "3006540014",
          "3011764595",
          "3014552222",
          "3021736516",
          "3011874573"
        ],
        "fei_number": [
          "3012787974",
          "3006540014",
          "3011764595",
          "3014552222",
          "3021736516",
          "3011874573"
        ],
        "device_name": "Dental Stereotaxic Instrument",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.4120",
        "device_class": "2"
      }
    }
  ]
}