{
  "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": "11",
      "code_info": "PS Tibial Insert Size 3  8mm,Part 163-1308,Lot A135943,PS Tibial Insert Size 3  9mm,Part 163-1309,Lot A136492,PS Tibial Insert Size 3  12mm,Part 163-1312,Lot A136453,PS Tibial Insert Size 4  7mm,Part 163-1407,Lot A135945,PS Tibial Insert Size 4  7mm,Part 163-1407,Lot A136454,PS Tibial Insert Size 5  9mm,Part 163-1509,Lot A135827,",
      "center_classification_date": "20140817",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the country of  Japan.  No military/govt/VA consignees.",
      "state": "UT",
      "product_description": "PS Tibial Insert, REF 163-1XXX    Product Usage:  UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component",
      "report_date": "20140827",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho Development Corporation",
      "recall_number": "Z-2255-2014",
      "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"
    }
  ]
}