{
  "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": "2026-07-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  "results": [
    {
      "cfres_id": "209984",
      "product_res_number": "Z-0209-2025",
      "event_date_initiated": "2024-08-30",
      "event_date_posted": "2024-10-24",
      "recall_status": "Open, Classified",
      "res_event_number": "95322",
      "product_code": "N/A",
      "product_description": "Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery",
      "code_info": "Software version v1.3",
      "firm_fei_number": "3008027912",
      "recalling_firm": "Blue Ortho 22 Chemin Du Vieux Chene Meylan France",
      "additional_info_contact": "Matthieu Coic\n04-58003525",
      "reason_for_recall": "Predict+ is being recalled for lack of pre-market clearance/approval.",
      "root_cause_description": "No Marketing Application",
      "action": "Blue Ortho issued a DHCP notice to its active users on 08/30/2024 via email.  The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.  There are no actions users need to take. Blue Ortho requested users confirm receipt of the email.",
      "product_quantity": "136 software units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {}
    }
  ]
}