{
  "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": "Portage",
      "address_1": "4100 E Milham Ave",
      "reason_for_recall": "Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.",
      "address_2": "",
      "product_quantity": "504",
      "code_info": "1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012       UDI: (01)7613252505983;  (01)7613252505969",
      "center_classification_date": "20180328",
      "distribution_pattern": "Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.",
      "state": "MI",
      "product_description": "1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969    for spinal orthopedic use.",
      "report_date": "20180404",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Instruments Div. of Stryker Corporation",
      "recall_number": "Z-1254-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "79418",
      "termination_date": "20190416",
      "more_code_info": "",
      "recall_initiation_date": "20171109",
      "postal_code": "49002-9704",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}