{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96806",
      "recalling_firm": "Straumann USA LLC",
      "address_1": "60 Minuteman Rd",
      "address_2": "N/A",
      "postal_code": "01810-1008",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.",
      "recall_number": "Z-1863-2025",
      "product_description": "GM Helix Acqua Implant, Article Number: 140.985",
      "product_quantity": "207 units (54 US, 153 OUS)",
      "reason_for_recall": "It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.",
      "recall_initiation_date": "20250501",
      "center_classification_date": "20250528",
      "report_date": "20250604",
      "code_info": "Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;"
    }
  ]
}