{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86762",
      "recalling_firm": "Zimmer Biomet, Inc.",
      "address_1": "1800 W Center St",
      "address_2": "N/A",
      "postal_code": "46580-2304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does  not apply to international customers.",
      "recall_number": "Z-0570-2021",
      "product_description": "Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system",
      "product_quantity": "57,715 units",
      "reason_for_recall": "Zimmer Biomet is conducting a medical device correction to update the Instructions  for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation  Screw and Cypher MIS Screw System. Users should be aware that changes were  made to the contraindications section indicating that the Translation Screws should  not be used with a direct current stimulation, as a high probability of construct failure  exists when using Translation Screws containing CoCr with direct current simulation  system.",
      "recall_initiation_date": "20201117",
      "center_classification_date": "20201215",
      "termination_date": "20210727",
      "report_date": "20201223",
      "code_info": "There have been 756 item numbers cleared in the US that are included in the recall  scope, as listed on the first tab of the attached ZFA 2020-00333 Affected Product  List. To date, there have only been products manufactured for a portion of the  affected item numbers. In addition, there are three kit part numbers affected as well.  The lot specific information is included on the second tab of the attached ZFA 2020-  0333 Affected Product List."
    }
  ]
}