{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Westlake Village",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92415",
      "recalling_firm": "Implant Direct Sybron Manufacturing LLC",
      "address_1": "3050 E Hillcrest Dr",
      "address_2": "N/A",
      "postal_code": "91362-3171",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of FL, ID, TX, CA.",
      "recall_number": "Z-2037-2023",
      "product_description": "LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE;  LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE;  LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE;  LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE  LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE;  LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;",
      "product_quantity": "29",
      "reason_for_recall": "Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.",
      "recall_initiation_date": "20230502",
      "center_classification_date": "20230629",
      "report_date": "20230705",
      "code_info": "REF/UDI-DI/Lot: 8730-81NE/10841307123002/92637, 131309; 8730-82NE/10841307123019/92638, 163063; 8735-80NNE/10841307123026/160542; 8735-82NE/10841307123064/15002360; 8745-80NNE/10841307123033/15004780; 8745-82NE/10841307123071/182029;",
      "more_code_info": ""
    }
  ]
}