{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Gainesville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88570",
      "recalling_firm": "Exactech, Inc.",
      "address_1": "2320 Nw 66th Ct",
      "address_2": "",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA  .",
      "recall_number": "Z-0022-2022",
      "product_description": "OPTETRAK Comprehensive Knee System custom devices labeled as the following:     a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX);     b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX);     c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX).       NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.",
      "product_quantity": "41 devices",
      "reason_for_recall": "Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.",
      "recall_initiation_date": "20210830",
      "center_classification_date": "20211004",
      "report_date": "20211013",
      "code_info": "a. Item Number (Device Identifier; Serial number(s)): 900-06-18 (10885862100375; 1667962, 1667963); 900-06-20 (10885862100382; 1667796, 1667797); 900-06-22(10885862100399; 1667744, 1667745); 900-08-18 (10885862100405; 1667794, 1667795); 900-08-20 (10885862100412; 1667929, 1667930); 900-08-22 (10885862100429; 1667879, 1667880);    b. Item Number (Device Identifier; Serial number(s)): 900-23-02 (10885862100863; 0899804, 0899805, 0899806, 0899807); 900-23-03 (10885862100870; 0900400, 0900401, 0900402, 0900403); 900-23-04 (10885862100887; 0900408, 0900409, 0900410, 0900411, 0900412); 900-23-05 (10885862100894; 0900413, 0900414, 0900415, 0900416); 900-23-06 (10885862100900; 0900404, 0900405, 0900406, 0900407); 900-30-11 (10885862101068; 0565754, 0565755); 900-30-13 (10885862101075; 0565756, 0565757);    c. Item Number (Device Identifier; Serial number(s)): 900-33-09 (10885862101082; 1822113,  1822114); 900-33-11 (10885862101099; 1822115, 1822116)",
      "more_code_info": ""
    }
  ]
}