{
  "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": "Wehrheim",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98078",
      "recalling_firm": "Heraeus Medical GmbH (Dental Division)",
      "address_1": "Philipp-Reis-Str. 8",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.",
      "recall_number": "Z-1081-2026",
      "product_description": "Brand Name: PALACOS  Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80  Model/Catalog Number: 5081288; 5081289  Software Version: N/A  Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application  system, suitable for use with or without vacuum (ready to mix).  Component: N/A",
      "product_quantity": "",
      "reason_for_recall": "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.",
      "recall_initiation_date": "20251209",
      "center_classification_date": "20260114",
      "report_date": "20260121",
      "code_info": "Lot Code: UDI-DI: 04260102136182; 04260102136212",
      "more_code_info": ""
    }
  ]
}