{
  "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": "West Chester",
      "address_1": "1302 Wrights Ln E",
      "reason_for_recall": "The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.",
      "address_2": "",
      "product_quantity": "148",
      "code_info": "Part number 687.030,  All Lots",
      "center_classification_date": "20130328",
      "distribution_pattern": "Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS,  KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY.",
      "state": "PA",
      "product_description": "Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set)    The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.",
      "report_date": "20130403",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Synthes USA HQ, Inc.",
      "recall_number": "Z-1016-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64271",
      "termination_date": "20150910",
      "more_code_info": "",
      "recall_initiation_date": "20130111",
      "postal_code": "19380-3417",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}