{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "124272",
      "product_res_number": "Z-0578-2014",
      "event_date_initiated": "2013-11-08",
      "event_date_posted": "2013-12-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-01-07",
      "res_event_number": "66935",
      "product_description": "ProPlan CMF  Guide(s) Model(s)\r\nREF SD900.008 Description: Single Use Only : Patient-Specific Guide,  Orthognathic, Final  Single  Use Only Rx only.\r\n\r\nUsed as surgical tools to transfer a pre-operative plan to surgery.\r\n.",
      "code_info": "Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2",
      "firm_fei_number": "3005718816",
      "recalling_firm": "Materialise USA LLC",
      "address_1": "44650 Helm Ct",
      "city": "Plymouth",
      "state": "MI",
      "postal_code": "48170-6061",
      "additional_info_contact": "Jenny Jones\n734-662-5057",
      "reason_for_recall": "Patient Specific Guide contained the incorrect case report.  The case report contains patient specific surgical plan information.",
      "root_cause_description": "Labeling Change Control",
      "action": "Customer/ ordering physician was made aware of the issue11/08/2013.  Revised accurate case report was immediately provided.",
      "product_quantity": "1",
      "distribution_pattern": "Distributed in Canada.",
      "openfda": {}
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}