{
  "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": "Draper",
      "address_1": "12187 Business Park Dr",
      "reason_for_recall": "Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.",
      "address_2": "",
      "product_quantity": "1",
      "code_info": "CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666",
      "center_classification_date": "20140817",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the country of  Japan.  No military/govt/VA consignees.",
      "state": "UT",
      "product_description": "Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY    Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed",
      "report_date": "20140827",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho Development Corporation",
      "recall_number": "Z-2257-2014",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "68898",
      "termination_date": "20141006",
      "more_code_info": "",
      "recall_initiation_date": "20140711",
      "postal_code": "84020-8663",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}