{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Plainsboro",
      "address_1": "311 Enterprise Dr",
      "reason_for_recall": "As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly.  The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium.",
      "address_2": "",
      "product_quantity": "12 units",
      "code_info": "Cat No. 10207205, Lot: QJ0248",
      "center_classification_date": "20160629",
      "distribution_pattern": "NC and PA",
      "state": "NJ",
      "product_description": "Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248",
      "report_date": "20160706",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corp.",
      "recall_number": "Z-2086-2016",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "74173",
      "termination_date": "20161019",
      "more_code_info": "",
      "recall_initiation_date": "20160429",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}