{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Gainesville",
      "address_1": "2320 NW 66th Ct",
      "reason_for_recall": "Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T.  Both trays have the potential to be mislabeled.",
      "address_2": "",
      "product_quantity": "16",
      "code_info": "Serial number range 2067442 - 2067457.",
      "center_classification_date": "20120724",
      "distribution_pattern": "Worldwide Distribution-USA-including the states of  CA, MA, OH, and OK,  and the countries of  Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain.",
      "state": "FL",
      "product_description": "Product is labeled in part:  \"***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***\".    The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.",
      "report_date": "20120801",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Exactech, Inc.",
      "recall_number": "Z-2070-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61969",
      "termination_date": "20140611",
      "more_code_info": "",
      "recall_initiation_date": "20110923",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}