{
  "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": "Davie",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80016",
      "recalling_firm": "Mako Surgical Corporation",
      "address_1": "2555 Davie Rd Ste 110",
      "address_2": "N/A",
      "postal_code": "33317-7424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI.      Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.",
      "recall_number": "Z-2051-2018",
      "product_description": "Restoris MCK Onlay Insert Extractor.",
      "product_quantity": "575 units total (400 US, 175 OUS)",
      "reason_for_recall": "Possible hinge pin disassociation from the Mako Onlay Insert Extractor.",
      "recall_initiation_date": "20180119",
      "center_classification_date": "20180601",
      "termination_date": "20200916",
      "report_date": "20180613",
      "code_info": "Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912.    Expanded scope: Lot No. 19150517, 19160517."
    }
  ]
}