{
  "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": [
    {
      "status": "Terminated",
      "city": "Hsinchu",
      "state": "N/A",
      "country": "Taiwan",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79321",
      "recalling_firm": "United Orthopedic Corporation",
      "address_1": "No. 57 Park Avenue 2, Science Park",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Distribution and to the countries of:  UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.",
      "recall_number": "Z-1128-2018",
      "product_description": "U2 Total Knee System Tibial Insert, Posterior Stabilized, #3,  11mm Thick Catalogue number 2303-3032    The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.",
      "product_quantity": "69 pieces",
      "reason_for_recall": "UOC received a customer compliant report from our distributor on October 31, 2017  which stated that contents of the package do not match the product labeling.",
      "recall_initiation_date": "20171124",
      "center_classification_date": "20180319",
      "termination_date": "20181009",
      "report_date": "20180328",
      "code_info": "Lot number 17B621AX"
    }
  ]
}