{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140801",
      "product_res_number": "Z-0136-2016",
      "event_date_initiated": "2015-08-06",
      "event_date_created": "2015-10-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-10-13",
      "res_event_number": "72366",
      "product_code": "GWO",
      "k_numbers": [
        "K121624"
      ],
      "product_description": "Neuro Combo Set Case\nThe cases hold surgical instrumentation in place during handling and storage.",
      "code_info": "Lot Code # 101337 Model # 17-5000",
      "firm_fei_number": "1032347",
      "recalling_firm": "Biomet Microfixation, LLC",
      "address_1": "1520 Tradeport Dr",
      "city": "Jacksonville",
      "state": "FL",
      "postal_code": "32218-2480",
      "additional_info_contact": "Rachel Osbeck\n904-741-9448",
      "reason_for_recall": "The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.",
      "root_cause_description": "Component change control",
      "action": "Biomet Microfixation made phone calls on August 6, 2015 and an initial notice letter sent via FedEx on August 6, 2015, to all distributors.  During the phone conversation the distributors confirmed that the inventory invoiced to them is currently in their possession and were asked to remove the lids from the trays and return them back to Biomet Microfixation. In conjunction to the Initial Notice, replacement lids were sent to their business address. Followup communication would be distributed until all units are returned to Biomet Microfixation.\nDistributors were instructed to do the following:\n \n1. Immediately locate and remove from circulation the items invoiced to your account as identified on this notice.\n2. Remove the lids from the quarantined units and replace with the lids (15-5001-18 or 19-5001-18) received with this Initial Notice. The new lids are being distributed to address the issue with the trays.\n3. Return the lids removed from the quarantined units to Zimmer Biomet CMF and Thoracic team with the labeling information provided with this notice.\nRETURN THIS LID: lot number(101337 or 101~65) located on the back of the lid\nDO NOT RETURN NEW LID: Part numbert  15-5001-18 or 1~5001-18 respectively\n4. Use the FedEx label in this packet to return the lids; this will be Zimmer Biomet's method of tracking your return. \n\n If distributors have further distributed this product, they must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field safety notices. Please understand it is your responsibility to locate and quarantine these products.  \n\nCustomers with questions were instructed to call at 1-800-874-7711 or 904-741-4400, extension 9574, Monday through Friday, 8am-4pm ET.",
      "product_quantity": "37 cases",
      "distribution_pattern": "Nationwide Distribution including CA, FL, OK, NY, NC, and IL.",
      "openfda": {
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          "K183352",
          "K141123",
          "K123723",
          "K140462",
          "K120352",
          "K861884",
          "K141452",
          "K182425",
          "K190229",
          "K112557",
          "K812952",
          "K153248",
          "K974206",
          "K203055",
          "K182711",
          "K261058",
          "K812951",
          "K250297",
          "K141644",
          "K100205",
          "K161446",
          "K141911",
          "K121624",
          "K231834",
          "K112812",
          "K122049",
          "K250334",
          "K861822",
          "K072758",
          "K903485",
          "K131775",
          "K111065",
          "K190811",
          "K073006"
        ],
        "registration_number": [
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          "1825034",
          "2029275",
          "1054811",
          "3034676720",
          "1057946",
          "2249697",
          "3009417901"
        ],
        "fei_number": [
          "",
          "1000125930",
          "3003018882",
          "3011530718",
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          "3017884860",
          "1825034",
          "1000306431",
          "3034676720",
          "3009417901"
        ],
        "device_name": "Plate, Cranioplasty, Preformed, Alterable",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5320",
        "device_class": "2"
      }
    }
  ]
}