{
  "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": "12",
      "code_info": "Serial number range 2067544 - 2067555.",
      "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 RBK***TIBIAL TRAY***FINNED,  CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***.    The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.",
      "report_date": "20120801",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Exactech, Inc.",
      "recall_number": "Z-2071-2012",
      "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"
    }
  ]
}