{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48367",
      "product_res_number": "Z-0012-2007",
      "event_date_initiated": "2006-02-27",
      "event_date_posted": "2006-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-10-05",
      "res_event_number": "36298",
      "product_code": "HPZ",
      "k_numbers": [
        "K982562"
      ],
      "product_description": "Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S",
      "code_info": "Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939",
      "firm_fei_number": "3009688114",
      "recalling_firm": "Integrated Orbital Implants Inc",
      "address_1": "12625 High Bluff Dr Ste 314 12625 High Bluff Dr",
      "address_2": "Ste 314",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92130-2054",
      "additional_info_contact": "Natalie J. Kennel\n858-705-0350",
      "reason_for_recall": "The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.",
      "root_cause_description": "Other",
      "action": "The recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors.\nBoth distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them.\nBoth distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.",
      "product_quantity": "8",
      "distribution_pattern": "Internationally to Finland & France",
      "openfda": {
        "k_number": [
          "K943275",
          "K053298",
          "K962241",
          "K023400",
          "K863943",
          "K212741",
          "K954939",
          "K082850",
          "K073293",
          "K110554",
          "K021357",
          "K900080",
          "K891137",
          "K895908",
          "K972143",
          "K040851",
          "K071335",
          "K040689",
          "K911110",
          "K781356",
          "K070130",
          "K862977",
          "K021643",
          "K083342",
          "K992294",
          "K123764",
          "K873578",
          "K900081",
          "K960859",
          "K934834",
          "K935251",
          "K003338",
          "K112176",
          "K982562",
          "K010902",
          "K941717",
          "K921106",
          "K915630",
          "K972661"
        ],
        "device_name": "Implant, Eye Sphere",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3320",
        "device_class": "2",
        "registration_number": [
          "3005528784",
          "1058584",
          "2518410",
          "2031962",
          "3004467263",
          "1225124",
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          "8010177"
        ],
        "fei_number": [
          "3002807041",
          "3000210020",
          "1000219637",
          "3005528784",
          "2518410",
          "3002445546",
          "3004467263",
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}