{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Gainesville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78936",
      "recalling_firm": "Exactech, Inc.",
      "address_1": "2320 NW 66th Ct",
      "address_2": "N/A",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to the states of :  AL, CA, CO, FL, MD. and NY",
      "recall_number": "Z-0538-2018",
      "product_description": "Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5      All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.",
      "product_quantity": "34",
      "reason_for_recall": "Wrong device description of the label identifying the implant",
      "recall_initiation_date": "20171009",
      "center_classification_date": "20180206",
      "termination_date": "20190806",
      "report_date": "20180214",
      "code_info": "Catalog #: 190-30-05  Serial#'s: 4897288, 4897291, 4897293, 4907465, 4907466, 4907467, 4907469, 4907472, 4907475, 4907476, 4907477, 4907478, 4907479, 4907481, 4943094, 4943095, 4943096, 4943097, 4943102, 4943104,   4943105, 4943106, 4984977, 4984978, 4984979, 4984980, 4984981,   4984982, 5046901, 5046902, 5046903, 5046904, 5046905, and 5046906."
    }
  ]
}