{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Palm Beach Gardens",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82263",
      "recalling_firm": "Biomet 3i, LLC",
      "address_1": "4555 Riverside Dr",
      "address_2": "N/A",
      "postal_code": "33410-4200",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide and Puerto Rico, Canada, and Australia",
      "recall_number": "Z-2140-2019",
      "product_description": "CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible",
      "product_quantity": "3 units",
      "reason_for_recall": "During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.",
      "recall_initiation_date": "20190226",
      "center_classification_date": "20190802",
      "termination_date": "20200615",
      "report_date": "20190814",
      "code_info": "Lot Numbers/UDI:    8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1"
    }
  ]
}