{
  "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": [
    {
      "status": "Terminated",
      "city": "Memphis",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66010",
      "recalling_firm": "Medtronic Sofamor Danek USA Inc",
      "address_1": "1800 Pyramid Place",
      "address_2": "N/A",
      "postal_code": "38132",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide Distribution in the state of GA, AK, WA, and CA.",
      "recall_number": "Z-2200-2013",
      "product_description": "T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA,     Product Usage:  The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.",
      "product_quantity": "9 units",
      "reason_for_recall": "One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant.  There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.",
      "recall_initiation_date": "20130812",
      "center_classification_date": "20130914",
      "termination_date": "20131227",
      "report_date": "20130925",
      "code_info": "RS12K008",
      "more_code_info": ""
    }
  ]
}