{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Palm Beach Gardens",
      "address_1": "4555 Riverside Dr",
      "reason_for_recall": "Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.",
      "address_2": "",
      "product_quantity": "10,454",
      "code_info": "All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx",
      "center_classification_date": "20140317",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico; and countries of:  Spain, Australia, Canada, Colombia, Japan, Uruguay, Mexico, Estonia, United Kingdom, Denmark, Germany, Spain, Italy, Poland, Ireland Netherlands, France, Sweden, Portugal, Australia, France, Belgium, Switzerland, Norway, Czech Republic, France, Holland, and Luxembourg.",
      "state": "FL",
      "product_description": "Dental Abutment labeled in part: \"4555 Riverside Drive Palm Beach Gardens, FL 33410 USA  1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.***    Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.",
      "report_date": "20140326",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Biomet 3i, LLC",
      "recall_number": "Z-1215-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66787",
      "termination_date": "20140926",
      "more_code_info": "",
      "recall_initiation_date": "20130826",
      "postal_code": "33410-4200",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}