{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "country": "United States",
      "city": "Center Valley",
      "address_1": "3773 Corporate Pkwy",
      "reason_for_recall": "The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance.   This issue does not affected sales outside the United States (OUS).",
      "address_2": "",
      "product_quantity": "167 Units",
      "code_info": "ELAN 4 Air System   ST0607 ELAN 4 Air Control Set   ST0608 ELAN 4 Air Neuro Crani Set   ST0609 ELAN 4 Air Spine Set   ST06411 ELAN 4 Air HD Spine Set   ST0614 ELAN 4 Air Micro Saw Set   ST0615 ELAN 4 Air Hand Control Set   ST0638 ELAN 4 Air Large Saw Set",
      "center_classification_date": "20180215",
      "distribution_pattern": "Nationwide Distribution.",
      "state": "PA",
      "product_description": "The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.",
      "report_date": "20180221",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Aesculap Implant Systems LLC",
      "recall_number": "Z-0623-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79092",
      "termination_date": "20190403",
      "more_code_info": "",
      "recall_initiation_date": "20170901",
      "postal_code": "18034-8217",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}