{
  "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": "160710",
      "product_res_number": "Z-0409-2018",
      "event_date_initiated": "2017-12-13",
      "event_date_posted": "2018-01-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-05",
      "res_event_number": "78840",
      "product_code": "OSN",
      "k_numbers": [
        "K142520"
      ],
      "product_description": "Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401.  A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.",
      "code_info": "Version 5.2.5 and 5.2.6",
      "firm_fei_number": "1020279",
      "recalling_firm": "Smith & Nephew, Inc.",
      "address_1": "1450 E Brooks Rd",
      "city": "Memphis",
      "state": "TN",
      "postal_code": "38116-1804",
      "additional_info_contact": "Dave Snyder\n978-749-1440",
      "reason_for_recall": "In rare circumstances, when surgeons use the software to plan the strut adjustment, an  inverted  image of the frame is generated by the software. The frame will appear  inverted  in the preview images on the Strut Settings tab.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm initiated their recall by email on 12/13/2017.  Users are asked if they notice an inverted frame in the software to repeat the process for the same case and notify a Smith & Nephew representative. In addition, they are asked to double check plannings for strut adjustments and compare with the images printed as described above.",
      "product_quantity": "N/A",
      "distribution_pattern": "Worldwide",
      "openfda": {
        "k_number": [
          "K140550",
          "K253764",
          "K221792",
          "K180539"
        ],
        "registration_number": [
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        "fei_number": [
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        "device_name": "Software For Diagnosis/Treatment",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3030",
        "device_class": "2"
      }
    }
  ]
}