{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Plantation",
      "address_1": "2555 Davie Rd Ste 110",
      "reason_for_recall": "The product may be mislabeled and could result in the incorrect implant being used.",
      "address_2": "",
      "product_quantity": "41 units",
      "code_info": "Part Number #180704-1, Lot #12151013-1.",
      "center_classification_date": "20140304",
      "distribution_pattern": "Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.",
      "state": "FL",
      "product_description": "Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.  Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.",
      "report_date": "20140312",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Mako Surgical Corporation",
      "recall_number": "Z-1132-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67444",
      "termination_date": "20140814",
      "more_code_info": "",
      "recall_initiation_date": "20140109",
      "postal_code": "33317-7424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}