{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Davie",
      "address_1": "2555 Davie Rd Ste 110",
      "reason_for_recall": "Out of tolerance.",
      "address_2": "",
      "product_quantity": "10,606",
      "code_info": "Lots #'s: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.",
      "center_classification_date": "20180813",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY  and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, Netherlands, Singapore, and United Kingdom",
      "state": "FL",
      "product_description": "Rio System Irrigation Clip - Catalog # 111690    Product Usage:  The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.",
      "report_date": "20180822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Mako Surgical Corporation",
      "recall_number": "Z-2794-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80552",
      "termination_date": "20210117",
      "more_code_info": "",
      "recall_initiation_date": "20180510",
      "postal_code": "33317-7424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}