{
  "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-2144-2020",
      "product_description": "Extremities  Item Number:  1)113954\t\tHybrid Glenoid Glenoid Base, 4 MM  2) XL-115366\tComprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard  3) XL-115364\tComprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard   Product Usage:  is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.",
      "product_quantity": "122 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:                      1)597000     UDI  (01)00880304462489(17)211229(10)597000  2) 502510    UDI  (01)00880304475458(17)211229(10)502510  3) 744880    UDI (01)00880304475434(17)220117(10)744880"
    }
  ]
}