{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Co. Cork Munster",
      "state": "",
      "country": "Ireland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91261",
      "recalling_firm": "Depuy Ireland UC",
      "address_1": "Loughbeg, Ringaskiddy",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Latvia, Lebanon, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, and Uruguay.",
      "recall_number": "Z-0951-2023",
      "product_description": "BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR    Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)",
      "product_quantity": "2199 US; 43515 OUS",
      "reason_for_recall": "All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.",
      "recall_initiation_date": "20221219",
      "center_classification_date": "20230112",
      "report_date": "20230118",
      "code_info": "Catalog Number Part Description UDI/DI * 546308000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 8 10603295174547 546310000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 10 10603295174554 546312000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12 10603295174561 546314000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 14 10603295174578 546316000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 16 10603295174585 546318000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 18 10603295174592 546320000     BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 20 10603295174608  * UDI-DI on GS1 0603295a0035792  Expiry dates December 2022 thru May 2025  ALL LOTS",
      "more_code_info": ""
    }
  ]
}