{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Rillieux La Pape",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86657",
      "recalling_firm": "Medicrea International",
      "address_1": "Vancia",
      "address_2": "Vancia",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "CA  Foreign:France, Belgium",
      "recall_number": "Z-0463-2021",
      "product_description": "MEDICREA LIGAPASS TENSION PULLEY HANDLE XS-  intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies  Ref : A08200200",
      "product_quantity": "17 units US; 8 units OUS  Expanded: 1 US and 3 OUS",
      "reason_for_recall": "Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery  and lead to a risk of infection and re-intervention ,",
      "recall_initiation_date": "20201008",
      "center_classification_date": "20201117",
      "termination_date": "20240509",
      "report_date": "20201125",
      "code_info": "Lot Numbers:  US: 17E0550-1, 17E1089R/2, 18E0278,  OUS: 19B0962, 19B0595, 19B0601    Expanded Recall: 11/3/20  17E0550/2, 19B0602, 19B0963 and 19B0964"
    }
  ]
}