{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Gainesville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77002",
      "recalling_firm": "Exactech, Inc.",
      "address_1": "2320 NW 66th Ct",
      "address_2": "N/A",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of :  AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA,  WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom",
      "recall_number": "Z-2644-2017",
      "product_description": "Exactech 1.5\" Novation Calcar Planer Guide Tip    To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.      ech 1.5\" Novation Calcar Planer Guide Tip",
      "product_quantity": "477",
      "reason_for_recall": "The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform  calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.",
      "recall_initiation_date": "20170522",
      "center_classification_date": "20170629",
      "termination_date": "20190726",
      "report_date": "20170705",
      "code_info": "Catalog #: 161-30-00 with the manufacturing lots #'s 38878-001, 38878-002, 49777-001, 51825-005, 51825-006, 52224-007, 51825-006, 52224-005, 52224-006, 57167-001, 59775-003, 62580-004, 66464-003, 66464-004, 70720-001, 71530-001, 73477-002, 75153-001, and 74999-001."
    }
  ]
}