{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Arlington",
      "state": "TN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86153",
      "recalling_firm": "MicroPort Orthopedics Inc.",
      "address_1": "5677 Airline Rd",
      "address_2": "N/A",
      "postal_code": "38002-9501",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "worldwide, except China and Japan",
      "recall_number": "Z-2941-2020",
      "product_description": "PROFEMUR Neck Long Titanium, Catalog Numbers:  PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264.  Hip prosthesis component.",
      "product_quantity": "123,284 units",
      "reason_for_recall": "MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation.  Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States  there were 349 Long and X-Long PROFEMUR¿ Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019.   There is an average time of 5.4 years to device fracture after implantation.",
      "recall_initiation_date": "20200731",
      "center_classification_date": "20200918",
      "termination_date": "20240416",
      "report_date": "20200930",
      "code_info": "All lots/serial numbers"
    }
  ]
}