{
  "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": "Cincinnati",
      "address_1": "4900 Charlemar Dr Bldg A",
      "reason_for_recall": "An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and  Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d",
      "address_2": "",
      "product_quantity": "eight (8) skull clamps were distributed",
      "code_info": "The recalled product is identified with the Lot Numbers: 096455 and 097546.",
      "center_classification_date": "20121219",
      "distribution_pattern": "Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.",
      "state": "OH",
      "product_description": "MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633.    The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.",
      "report_date": "20121226",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corporation",
      "recall_number": "Z-0559-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63776",
      "termination_date": "20140221",
      "more_code_info": "",
      "recall_initiation_date": "20121105",
      "postal_code": "45227-1402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}