{
  "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-2153-2020",
      "product_description": "Knee   Products:  183742\t        Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM  EP-183608\tVanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  EP-183608\tVanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  183744\t        Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM  183742\t        Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM  EP-183608\tVanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  EP-183608\tVanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  Product Usage: Knee prosthesis",
      "product_quantity": "93 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  294130 Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130  509970 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970  509990 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990  175980 Knees Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM (01)00880304438354(17)220114(10)175980  294130R Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130R  509970R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970R  509990R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990R"
    }
  ]
}