{
  "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": "Lewisville",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79819",
      "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": "U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,",
      "recall_number": "Z-2128-2018",
      "product_description": "H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number):   a) 12MM Spacer (003-H-12001);   b) 15MM Spacer  (003-H-15001);   20MM Spacer (003-H-20001);   25MM Spacer (003-H-25001);   30 MM (003-H-30001)",
      "product_quantity": "75",
      "reason_for_recall": "Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.",
      "recall_initiation_date": "20180406",
      "center_classification_date": "20180607",
      "termination_date": "20210630",
      "report_date": "20180613",
      "code_info": "Lot: B1212400, Date of Manufacture: 2017-11-13, Use By: 2022-10-13, (UDI)/Lot:   a) (18056099647908) B1096740;  b) (18056099647915) B1096733;  c) (18056099647939) B1096734;  d) (18056099647953) B1096735;  e) (18056099647960) B1100226"
    }
  ]
}