{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91147",
      "recalling_firm": "Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International distribution in the country of Turkey.",
      "recall_number": "Z-0736-2023",
      "product_description": "Full Dose CE Simplex P Single Bone Cement\t- Indicated for the fixation of prostheses to living bone in orthopaedic  Catalog Number: 6191-0-001",
      "product_quantity": "2085 units",
      "reason_for_recall": "Instructions for Use (IFU) included in the packaging  is missing a translation in the Turkish language.  Although the Turkish translation is missing, all content within the IFUs is accurate.",
      "recall_initiation_date": "20221107",
      "center_classification_date": "20221220",
      "report_date": "20221228",
      "code_info": "UDI#  P/N 6191-0-001 (01)07613327128772 (17)261031(10)lot# GTIN: 07613327128772 -Instructions for Use (IFU) received with product: 0700-7-010  (IFU Radiopaque Bone Cement)  All lots manufactured under Rev AB, with Exp. Date  on/after September 16, 2021.",
      "more_code_info": ""
    }
  ]
}