{
  "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": "86402",
      "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": "Letter",
      "distribution_pattern": "FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA",
      "recall_number": "Z-0077-2021",
      "product_description": "CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM  Reference Number: IEDAT4",
      "product_quantity": "35 units",
      "reason_for_recall": "Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient",
      "recall_initiation_date": "20200831",
      "center_classification_date": "20201008",
      "termination_date": "20220706",
      "report_date": "20201014",
      "code_info": "Lot Numbers:  8560281-1  8560299-1  8561332-3  8561476-1  8563315-1  8564057-1  8564060-3  8564060-4  8564064-1  8564524-1  8564524-2  8565357-1  8565414-3  8566637-1  8566637-2  8566648-1  8566969-2  8567559-1  8567578-1  8568041-1  8568705-1  8568819-1  8569841-7  8569987-1  8570625-1  8570737-1  8571824-1  8571843-1  8571850-1  8571866-1  8571887-4  8571887-5  8572228-1  8572238-1  8572238-2  UDI:   (01)00844868031185(10)8560281-1    (01)00844868031185(10)8560299-1    (01)00844868031185(10)8561332-3    (01)00844868031185(10)8561476-1    (01)00844868031185(10)8563315-1    (01)00844868031185(10)8564057-1    (01)00844868031185(10)8564060-3    (01)00844868031185(10)8564060-4    (01)00844868031185(10)8564064-1    (01)00844868031185(10)8564524-1    (01)00844868031185(10)8564524-2    (01)00844868031185(10)8565357-1    (01)00844868031185(10)8565414-3    (01)00844868031185(10)8566637-1    (01)00844868031185(10)8566637-2    (01)00844868031185(10)8566648-1    (01)00844868031185(10)8566969-2    (01)00844868031185(10)8567559-1    (01)00844868031185(10)8567578-1    (01)00844868031185(10)8568041-1    (01)00844868031185(10)8568705-1    (01)00844868031185(10)8568819-1    (01)00844868031185(10)8569841-7    (01)00844868031185(10)8569987-1    (01)00844868031185(10)8570625-1    (01)00844868031185(10)8570737-1    (01)00844868031185(10)8571824-1    (01)00844868031185(10)8571843-1    (01)00844868031185(10)8571850-1    (01)00844868031185(10)8571866-1    (01)00844868031185(10)8571887-4  (01)00844868031185(10)8571887-5  (01)00844868031185(10)8572228-1  (01)00844868031185(10)8572238-1    01)00844868031185(10)8572238-2"
    }
  ]
}