{
  "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": "26349",
      "product_res_number": "Z-0781-03",
      "event_date_initiated": "2003-02-26",
      "event_date_posted": "2003-04-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-12-01",
      "res_event_number": "25715",
      "product_code": "GZT",
      "k_numbers": [
        "K830332"
      ],
      "product_description": "Halo Support Bracket Assembly (Part #438-B1010).  The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component.  The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly.",
      "code_info": "Lot # 031 - etched on the side of the Clamp Assembly",
      "firm_fei_number": "1525725",
      "recalling_firm": "Ohio Medical Instrument Co Inc",
      "address_1": "4900 Charlemar Dr",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45227",
      "reason_for_recall": "The component was manufactured with an insufficient weld that could break during use.",
      "root_cause_description": "Other",
      "action": "The firm contacted their accounts by email and telephone on 2/26/2003.",
      "product_quantity": "43 components",
      "distribution_pattern": "The units were shipped to domestic consignees in NY, NJ, IL, and FL;  and to foreign customers located in Japan, Hong Kong, Korea, Great Britian, and Germany.",
      "openfda": {
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          "K071771",
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          "K992898",
          "K924876",
          "K062814",
          "K905445",
          "K071338",
          "K161318",
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        "device_name": "Retractor, Self-Retaining, For Neurosurgery",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4800",
        "device_class": "2"
      }
    }
  ]
}