{
  "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": "Warsaw",
      "address_1": "700 Orthopaedic Dr",
      "reason_for_recall": "The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.",
      "address_2": "",
      "product_quantity": "85",
      "code_info": "Lot #  8556802, 8556803, 8556804, 8556805, 8583381, 8556910, 8556951, 8605849, 8564487, 8572431, 8610357, 8527674.",
      "center_classification_date": "20180314",
      "distribution_pattern": "Distribution Level: The device removal is extended to the companies US Distributors/Sales Offices and Medical Facilities that may have used, purchased, or received the affected devices. Approximately 53 units distributed to firm's international affiliates.",
      "state": "IN",
      "product_description": "The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling:  LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf",
      "report_date": "20180321",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "DePuy Orthopaedics, Inc.",
      "recall_number": "Z-1012-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79257",
      "termination_date": "20200327",
      "more_code_info": "",
      "recall_initiation_date": "20171128",
      "postal_code": "46582-3994",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}