{
  "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": [
    {
      "country": "United States",
      "city": "Lewisville",
      "address_1": "3451 Plano Pkwy",
      "reason_for_recall": "Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or  (2)\tthe driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.",
      "address_2": "",
      "product_quantity": "397 units",
      "code_info": "UDI 18257200125371, Lot Numbers:  O02, O03 and O04",
      "center_classification_date": "20180411",
      "distribution_pattern": "US",
      "state": "TX",
      "product_description": "ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003",
      "report_date": "20180418",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Orthofix, Inc",
      "recall_number": "Z-1363-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79498",
      "termination_date": "20190618",
      "more_code_info": "",
      "recall_initiation_date": "20180223",
      "postal_code": "75056-9453",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}