{
  "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": "2026-07-08",
    "results": {
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  "results": [
    {
      "status": "Ongoing",
      "city": "San Daniele Del Friuli",
      "state": "",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95732",
      "recalling_firm": "Limacorporate S.p.A",
      "address_1": "Via Nazionale 52",
      "address_2": "Di San Daniele",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "U.S: FL and TX  O.U.S.: N/A",
      "recall_number": "Z-0744-2025",
      "product_description": "TEMA Elbow - Axle Small REF 1590.15.010    TEMA Elbow - Axle Large REF 1590.15.020    TEMA Elbow System is a cemented total elbow prosthesis.",
      "product_quantity": "~87 devices (U.S.)",
      "reason_for_recall": "Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.",
      "recall_initiation_date": "20241002",
      "center_classification_date": "20241220",
      "report_date": "20250101",
      "code_info": "Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087  Product/Catalog Number: 1590.15.020  TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193",
      "more_code_info": ""
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}