{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197346",
      "product_res_number": "Z-0951-2023",
      "event_date_initiated": "2022-12-19",
      "event_date_posted": "2023-01-12",
      "recall_status": "Open, Classified",
      "res_event_number": "91261",
      "product_code": "LZN",
      "k_numbers": [
        "K943727"
      ],
      "product_description": "BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR\n\nCatalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)",
      "code_info": "Catalog Number\tPart Description\tUDI/DI *\n546308000\tBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 8\t10603295174547\n546310000\tBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 10\t10603295174554\n546312000\tBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12\t10603295174561\n546314000\tBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 14\t10603295174578\n546316000\tBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 16\t10603295174585\n546318000\tBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 18\t10603295174592\n546320000     BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 20 10603295174608\n\n* UDI-DI on GS1 0603295a0035792\n\nExpiry dates December 2022 thru May 2025\n\nALL LOTS",
      "firm_fei_number": "3015516266",
      "recalling_firm": "Depuy Ireland UC",
      "address_1": "Loughbeg, Ringaskiddy Loughbeg",
      "city": "Ringaskiddy Co. Cork",
      "state": "Munster",
      "country": "Ireland",
      "additional_info_contact": "Kimberly Long\n574-2218156",
      "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.",
      "root_cause_description": "Process control",
      "action": "On December 19, 2022, the firm notified affected consignees through \"Urgent Medical Device Recall\" letters. Customers were instructed to immediately identify and quarantine affected product in inventory. Recalled products should not be used. Customers should then contact Sedgwick at synthes5716@sedgwick.com or call 888-597-5387  to coordinate the return/credits of the subject products.",
      "product_quantity": "2199 US; 43515 OUS",
      "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.",
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          "K942060",
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          "K951930",
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        "registration_number": [
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        "fei_number": [
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          "1000220733",
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        ],
        "device_name": "Cement Obturator",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.3300",
        "device_class": "2"
      }
    }
  ]
}