{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Trevoux",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79662",
      "recalling_firm": "Sofradim Production",
      "address_1": "116 avenue de Formans",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution to the states of:  CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, PA, TN, TX, VA, WA and WI, and to the countries of : Belgium, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Russian Federation, Spain, Switzerland, and UK.",
      "recall_number": "Z-1523-2018",
      "product_description": "Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M    The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.",
      "product_quantity": "703",
      "reason_for_recall": "There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.",
      "recall_initiation_date": "20180223",
      "center_classification_date": "20180426",
      "termination_date": "20200512",
      "report_date": "20180502",
      "code_info": "UDI - 10884521532298    Lots  SPC1091X  SPJ0706X  SPJ1016X  SQA0990X  SQI0302X  SQJ0443X  SQK0319X  SRA2188X  SRI0548X"
    }
  ]
}