{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "114755",
      "product_res_number": "Z-0559-2013",
      "event_date_initiated": "2012-11-05",
      "event_date_posted": "2012-12-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-02-21",
      "res_event_number": "63776",
      "product_code": "HBL",
      "k_numbers": [
        "K120633"
      ],
      "product_description": "MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633.\n\nThe MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.",
      "code_info": "The recalled product is identified with the Lot Numbers: 096455 and 097546.",
      "firm_fei_number": "3004608878",
      "recalling_firm": "Integra LifeSciences Corporation",
      "address_1": "4900 Charlemar Dr Bldg A 4900 Charlemar Dr",
      "address_2": "Bldg A",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45227-1402",
      "additional_info_contact": "Michael Molloy\n513-533-7979",
      "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",
      "root_cause_description": "Under Investigation by firm",
      "action": "Integra issued an 'Urgent:  Voluntary Medical Device Recall Notification with 'Recall Acknowledgment and Return Form' to all Integra Sales Representatives and Customers via visit and E-mail on November 5, 2012.  The recall notice informs the customers of the firm's receipt of  complaints pin-pointing quality issues with the MAYFIELD Base Units and MAYFIELD Skull Clamps which may impair their functionality. The customers are asked to sign and return the enclosed Recall Acknowledgement and Return Form so as to document their receipt of the recall notification and replacement products.  The replacement products are to be delivered by the Integra NeuroSpecialist who is also responsible for returning the signed forms to Integra as documentation that the recalled devices have been replaced. Should the customer(s) have questions or concerns, they are directed to contact Integra Customer Service at: 1-877-444-1114,Option 3 for Technical Support.",
      "product_quantity": "eight (8) skull clamps were distributed",
      "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.",
      "openfda": {
        "k_number": [
          "K191701",
          "K250423",
          "K071458",
          "K941558",
          "K103493",
          "K955012",
          "K893911",
          "K113748",
          "K821772",
          "K130389",
          "K053045",
          "K090506",
          "K083803",
          "K001808",
          "K203505",
          "K073163",
          "K021604",
          "K163322",
          "K002276",
          "K072208",
          "K923789",
          "K241883",
          "K141950",
          "K002990",
          "K913170",
          "K911772",
          "K091439",
          "K090695",
          "K120633",
          "K031885",
          "K240319",
          "K191979",
          "K934289",
          "K051440",
          "K901393",
          "K912005",
          "K122225",
          "K193438",
          "K953124",
          "K063494",
          "K191740",
          "K932860",
          "K911723",
          "K032331",
          "K081401",
          "K874298",
          "K932807",
          "K050319",
          "K912011",
          "K142238"
        ],
        "device_name": "Holder, Head, Neurosurgical (Skull Clamp)",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4460",
        "device_class": "2",
        "registration_number": [
          "3002250546",
          "1722447",
          "1054811",
          "1923569",
          "1721676",
          "3007515069",
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          "1531062",
          "3011689956",
          "2182207",
          "3013557562",
          "3004929307",
          "3003418325",
          "3003768277"
        ],
        "fei_number": [
          "3002250546",
          "1000306431",
          "1923569",
          "1721676",
          "3007515069",
          "3018094310",
          "3002619595",
          "3003923579",
          "3010326005",
          "3011547624",
          "3009217531",
          "3009882462",
          "3003923584",
          "3002807880",
          "1000114185",
          "3013111980",
          "3004608878",
          "3028006458",
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          "3009077524",
          "3009504761",
          "1000127185",
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          "3004143769",
          "3011689956",
          "2182207",
          "1000138491",
          "3013557562",
          "3004929307",
          "3003418325"
        ]
      }
    }
  ]
}