{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lewisville",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62804",
      "recalling_firm": "Orthofix, Inc",
      "address_1": "3451 Plano Pkwy",
      "address_2": "N/A",
      "postal_code": "75056-9453",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Internationally to Australia, Hong Kong, Saudi Arabia, Korea, Turkey, Greece, Finland, South Africa, Spain, Singapore, Switzerland, Brazil, Germany, France, Japan, Netherlands, New Zealand, Israel, Canada and Mexico",
      "recall_number": "Z-0895-2013",
      "product_description": "Orthofix ISKD Limb Lengthener.  ISKD - Intramedullary Skeletal Kinetic Distractor.      The ISKD is intended for limb lengthening of the tibia and femur.",
      "product_quantity": "1224",
      "reason_for_recall": "There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.",
      "recall_initiation_date": "20120806",
      "center_classification_date": "20130228",
      "termination_date": "20130517",
      "report_date": "20130306",
      "code_info": "All serial numbers of the following Catalog Numbers:  F12-255-305, F12-345-395NS, T12-245-295, F12-255-305NS, F12-345-425, T12-255-305, F12-255-335, F12-345-425NS, T12-255-305NS, F12-255-335NS, T10-215-265, T12-255-335, F12-300-350, T10-255-305, T12-255-335NS, F12-300-350NS, T10-255-335, T12-300-350, F12-300-380, T10-300-350, T12-300-350NS, F12-300-380NS, T12-215-265, T12-300-380, F12-345-395, T12-215-265NS, and T12-300-380NS"
    }
  ]
}