{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ivry Le Temple",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69879",
      "recalling_firm": "PEROUSE MEDICAL",
      "address_1": "ROUTE DU MANOIR",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution in the states of AZ and CO.",
      "recall_number": "Z-0877-2015",
      "product_description": "Synthes Inflation System (03.804.4135)     Product Usage:  Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter",
      "product_quantity": "2184 units",
      "reason_for_recall": "Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure",
      "recall_initiation_date": "20141006",
      "center_classification_date": "20141229",
      "termination_date": "20170324",
      "report_date": "20150107",
      "code_info": "Batch numbers:  4041354/4062650/4072586"
    }
  ]
}