{
  "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": "2026-08-13",
    "results": {
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  "results": [
    {
      "cfres_id": "104774",
      "product_res_number": "Z-0374-2012",
      "event_date_initiated": "2011-10-10",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-10-01",
      "res_event_number": "60214",
      "product_code": "FST",
      "k_numbers": [
        "K864380"
      ],
      "product_description": "Luxtec UltraLite Headlight System with 9ft premium bifurcated cable\nModel: AX2100BIF\n\n\nProduct Usage:  The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.",
      "code_info": "All serial numbers",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "city": "Plainsboro",
      "state": "NJ",
      "postal_code": "08536-3344",
      "additional_info_contact": "Jeanne Pantalion\n609-275-0500",
      "reason_for_recall": "Headlight assembly (module) may become loose and separate from the headband assembly",
      "root_cause_description": "Device Design",
      "action": "Integra Life Sciences notified consignees by URGENT DEVICE RECALL letter dated October 10, 2011, via FedEx, email or telephone conference calls. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to identify and return any affected product.  Customers were requested to complete and return the attached Field Corrective Action Acknowledgement Form to Integra Surgical indicating receipt and review of this notification.  For assistance and additional information contact your local and Integra Sales Representative or call Integra Surgical Customer Service at 1-800-431-1123.",
      "product_quantity": "965 units",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of: Africa, Algeria, Australia, Austria, Brazil, Canada, Check Republic, China, Chile, Costa Rica, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece Hungary, Guatemala, India, Ireland, Israel, Italy, Iraq, Japan, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Macedonia, Mexico, Netherlands, New Zealand! Norway, Oman, Pakistan, Peru Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain,  Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Qatar, United Kingdom, Yemeni United Arab Emirates, Uruguay, and Venezuela.",
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        ],
        "device_name": "Light, Surgical, Fiberoptic",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4580",
        "device_class": "2",
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