{
  "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": "Memphis",
      "address_1": "3973 Delp St",
      "reason_for_recall": "Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%.   For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.",
      "address_2": "",
      "product_quantity": "12,768 units",
      "code_info": "all serial numbers",
      "center_classification_date": "20171220",
      "distribution_pattern": "nationwide",
      "state": "TN",
      "product_description": "The GMK knee system:  designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges:  02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF",
      "report_date": "20171227",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medacta Usa Inc",
      "recall_number": "Z-0266-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "78401",
      "termination_date": "20180620",
      "more_code_info": "",
      "recall_initiation_date": "20171024",
      "postal_code": "38118-6110",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}