{
  "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": "Mcmurray",
      "address_1": "200 Hidden Valley Rd",
      "reason_for_recall": "Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.",
      "address_2": "",
      "product_quantity": "553",
      "code_info": "part numbers SC3425 and SC3453, with lot numbers:28592-103112  28593-102412  28602-110112  28603-110112  28613-110112  28617-110112  28618-110112  28622-112812  28623-112812  28624-112812  31031-121013  31033-121013  31040-121013  31249-022514  31261-020414  28592-103112  28593-102412  28598-111412  28599-111412  28602-110112  28603-110112  28607-111912  28613-110112  28617-110112  28618-110112  28622-112812  28623-112812  28624-112812  31029-120913  31040-121013  31043-120913  31243-022414  31244-022414  31249-022514  31252-021314  31255-020414  31261-020414  32083-080714  31028-120913  31031-121013  31032-121013  31033-121013  31042-121013  31044-120913  31243-022414  31244-022414  31245-022414  31252-021314  31255-020414  31261-020414  31263-021314  31264-031114  31265-031114  31266-031114  28592-103112  28593-102412  28598-111412  28599-111412  28602-110112  28603-110112  28607-111912  28613-110112  28617-110112  28618-110112  28622-112812  28623-112812  28624-112812  31029-120913  31034-120913  31040-121013  31043-120913  31044-120913  31249-022514  31255-020414  32083-080714  28592-103112  28593-102412  28598-111412  28599-111412  28602-110112  28603-110112  28607-111912  28613-110112  28617-110112  28618-110112  28622-112812  28623-112812  28624-112812  31028-120913  31029-120913  31031-121013  31032-121013  31033-121013  31034-120913  31037-121013  31040-121013  31042-121013  31044-120913  31243-022414  31244-022414  31245-022414  31249-022514  31252-021314  31255-020414  31261-020414  31263-021314  31265-031114  32081-080714  28592-103112  28593-102412  28598-111412  28599-111412  28602-110112  28603-110112  28613-110112  28622-112812  28623-112812  28624-112812  31034-120913  28599-111412  28617-110112  31028-120913  31032-121013  31042-121013  31044-120913  31243-022414  31244-022414  31245-022414  31249-022514  31251-022514  31252-021314  31255-020414  31261-020414  31263-021314  31264-031114  31265-031114  31266-031114  28618-110112  28592-103112  28598-103112  28599-111412  28602-110112  28603-110112  28607-111912  28613-110112  28617-110112  28618-110112  28622-112812  28623-112812",
      "center_classification_date": "20150114",
      "distribution_pattern": "TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.",
      "state": "PA",
      "product_description": "EXp Tibial Insert ; Intended Use of Device(s):  The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.",
      "report_date": "20150121",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stelkast Co",
      "recall_number": "Z-0970-2015",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "70082",
      "termination_date": "20150506",
      "more_code_info": "",
      "recall_initiation_date": "20141201",
      "postal_code": "15317-2659",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}