{
  "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": "Norderstedt",
      "state": "",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94814",
      "recalling_firm": "Waldemar Link GmbH & Co. KG (Mfg Site)",
      "address_1": "Oststr. 4-10",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide Foreign:  Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam",
      "recall_number": "Z-2411-2024",
      "product_description": "Endo Model  SL Tibial Components\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t  16-2817/02\tTibial Component, Small, W: 60mm  16-2817/05\tTibial Component, Medium, W: 65mm  16-2817/07\tTibial Component, Large, W: 75mm  16-2817/32\tTibial Component Modular, Small, W: 60mm  16-2817/35\tTibial Component Modular, Medium, W: 65mm  16-2817/37\tTibial Component Modular, Large, W: 75mm",
      "product_quantity": "114 units US;  2351 units OUS",
      "reason_for_recall": "Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique",
      "recall_initiation_date": "20240522",
      "center_classification_date": "20240718",
      "report_date": "20240724",
      "code_info": "Product                        UDI-DI 16-2817/02            04026575359202; 16-2817/05            04026575359219; 16-2817/07            04026575359226; 16-2817/32            04026575370870; 16-2817/35            04026575370887; 16-2817/37            04026575370894.  All product lots manufactured since 01-Jun-2022.",
      "more_code_info": ""
    }
  ]
}