{
  "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": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85524",
      "recalling_firm": "Biomet, Inc.",
      "address_1": "56 E Bell Dr",
      "address_2": "N/A",
      "postal_code": "46582-6989",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY,                        HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE,                             SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.",
      "recall_number": "Z-2149-2020",
      "product_description": "Knee Products:  155308\tKnees\tAGC Knee System PS Molded Tibial Component, 10 MM X 65 MM  155326\tKnees\tAGC Knee System PS Molded Tibial Component, 10 MM X 70 MM  155330\tKnees\tAGC Knee System PS Molded Tibial Component, 14 MM X 70 MM  155344\tKnees\tAGC Knee System PS Molded Tibial Component, 10 MM X 75 MM  155346\tKnees\tAGC Knee System PS Molded Tibial Component, 12 MM X 75 MM  155326\tKnees\tAGC Knee System PS Molded Tibial Component, 10 MM X 70 MM  155328\tKnees\tAGC Knee System PS Molded Tibial Component, 12 MM X 70 MM  155388\tKnees\tAGC Knee System PS Molded Tibial component, 18 MM X 85 MM  Product Usage: Knee prosthesis",
      "product_quantity": "54 units",
      "reason_for_recall": "Potential presence of elevated endotoxin levels that exceed the specification limit",
      "recall_initiation_date": "20200417",
      "center_classification_date": "20200528",
      "termination_date": "20210625",
      "report_date": "20200603",
      "code_info": "Lot Numbers:   UDI Number  570460 AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM (01)00880304000865(17)220111(10)570460  515880 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220106(10)515880  602810 AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM (01)00880304246034(17)220105(10)602810  494090 AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM (01)00880304003781(17)220106(10)494090  505320 AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM (01)00880304246096(17)220106(10)505320  578470 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220114(10)578470  447820 AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM (01)00880304000179(17)220118(10)447820  494030 AGC Knee System PS Molded Tibial component, 18 MM X 85 MM (01)00880304246256(17)220118(10)494030"
    }
  ]
}