{
  "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": "Cincinnati",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70088",
      "recalling_firm": "Integra LifeSciences Corporation",
      "address_1": "4900 Charlemar Dr Bldg A",
      "address_2": "N/A",
      "postal_code": "45227-1402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of:  AK,  AL,  AR,  AZ,  CA,  CO,  CT,  DC,  DE,  FL,  GA,  HI,  IA,  ID,  IL, IN,  KS,  KY,  LA,  MA,  MD,  ME,  MI,  MN,  MO,  MS,  MT,  NC,  NE,  NH,  NJ,  NM,  NV,  NY,  OH,  OK,  OR,  PA,  RI,  SC,  TN,  TX,  UT,  VA,  WA,  WI,  WV,  WY, and DC. (25 government consignees) and in the foreign countries: CANADA, ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, COLUMBIA, CYPRESS, DENMARK, DOMINICAN REPUBLIC, FRANCE, GERMANY, GREAT BRITAN, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN , JORDAN, KOREA, LIBYA, MACEDONIA, MAYLASIA, MEXICO, NETHERLANDS, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, TAIWAN, THAILAND, and TURKEY.",
      "recall_number": "Z-1084-2015",
      "product_description": "The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package.    Product Usage:      This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.",
      "product_quantity": "1053 Units",
      "reason_for_recall": "Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.",
      "recall_initiation_date": "20141219",
      "center_classification_date": "20150210",
      "termination_date": "20170222",
      "report_date": "20150218",
      "code_info": "All Lot numbers of Mayfield Ultra 360 Base Units, Catalogue #'s A2009 and A2029.     Affected Lot Numbers For Catalogue No. A2009   73149, 73355, 73356, 74396, 74730, 74398, 74399, 75796, 75816, 74523, 75838, 75859, 74524, 75873, 74890, 75939, 74892, 76420, 74893, 74894, 74895, 76156, 77225, 76157, 76158, 77831, 76159, 77957, 76160, 78012, 76161, 78548, 77292, 78666, 79067, 79068, 79069, 79071, 80013, 79073, 81782, 79074, 81918, 79075, 79748, 80094, 82194, 80095, 80668, 80669, 84171, 80671, 84288, 82736, 82737, 82738, 85896, 82739, 86400, 82740, 82741, 82742, 84732, 84733, 84734, 84735, 85693, 86817, 86818, 86819, 86820, 86821, 86822, 89453, 89455, 89456, 89457, 92296, 92297, 92298, 92299, 92300, 92301, 94653, 94654, 94655, 99798, 98558, 98559, 98560, 98561, 98562, 94658, 103127, 103128, 103129, 103130, 103131, 104890, 114978, 115809, E19251, 123051    Affected Lot Numbers For Catalogue No. A2029  84180, 84487, 85519, 85815, 85631, 84887, 84888, 86533, 86534, 84889, 86828, 86829, 89302, 86830, 86831, 86832, 86833, 86834, 89534, 89535, 89536, 89537, 89538, and 94167."
    }
  ]
}