{
  "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": [
    {
      "status": "Terminated",
      "city": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64771",
      "recalling_firm": "Synthes USA HQ, Inc.",
      "address_1": "1302 Wrights Ln E",
      "address_2": "N/A",
      "postal_code": "19380-3417",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI.",
      "recall_number": "Z-1238-2013",
      "product_description": "Synthes Radial Head Prosthesis: Trial Radial Head    Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.",
      "product_quantity": "417",
      "reason_for_recall": "The Trial Head may come loose from the implant stem during manipulation of the arm during surgery.  To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.",
      "recall_initiation_date": "20130222",
      "center_classification_date": "20130503",
      "termination_date": "20150831",
      "report_date": "20130515",
      "code_info": "All Lots of Part Numbers:  03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628."
    }
  ]
}