{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "104320",
      "product_res_number": "Z-0613-2012",
      "event_date_initiated": "2011-08-08",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-09-27",
      "res_event_number": "60049",
      "product_code": "KOG",
      "k_numbers": [
        "K070671"
      ],
      "product_description": "OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer",
      "code_info": "Lot Numbers 113086, 107304, 110511, and 112473",
      "firm_fei_number": "3009124511",
      "recalling_firm": "Innovatech Medical Resources L.P.",
      "address_1": "5455 Honeysuckle Road",
      "city": "Midlothian",
      "state": "TX",
      "postal_code": "76065",
      "reason_for_recall": "Product is being removed from the field due to an over-label issue.",
      "root_cause_description": "Reprocessing Controls",
      "action": "Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility.  A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it.  Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product.\r\n\r\nFor questions regarding this recall call 817-714-9066.",
      "product_quantity": "Lot Number (QTY): 113086 (1 unit), 107304 (1 unit), 110511 (1 unit), and 112473 (2 units)",
      "distribution_pattern": "Nationwide Distribution including Texas",
      "openfda": {}
    }
  ]
}