{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
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  "results": [
    {
      "country": "United States",
      "city": "Palm Beach Gardens",
      "address_1": "4555 Riverside Dr",
      "reason_for_recall": "Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611.  The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.",
      "address_2": "",
      "product_quantity": "240",
      "code_info": "Lot Number 2011110798",
      "center_classification_date": "20120808",
      "distribution_pattern": "Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.",
      "state": "FL",
      "product_description": "***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798.    Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.",
      "report_date": "20120815",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Biomet 3i, LLC",
      "recall_number": "Z-2158-2012",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "62375",
      "termination_date": "20131216",
      "more_code_info": "",
      "recall_initiation_date": "20120323",
      "postal_code": "33410-4200",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}