{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "113241",
      "product_res_number": "Z-0216-2013",
      "event_date_initiated": "2012-09-04",
      "event_date_posted": "2012-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-04-16",
      "res_event_number": "63103",
      "product_code": "KXA",
      "k_numbers": [
        "K070292"
      ],
      "product_description": "Metasul Durom Femoral component\nSterile, Rx",
      "code_info": "REF Numbers: 01.00211.140, 01.00211.144, 01.00211.152, 01.00211.154. 01.00211.156, 01.00211.158, and 01.00211.160. Lot:  2367454, 2367454, 2367454, 2367454, 2367455, 2367455, 2374382, 2374382, 2374382, 2374382, 2381632, 2381632, 2381634, 2381634, 2409055, 2414048, 2397713, 2397713, 2417888, 2380622, 2380622, 2388389, 2388389, 2388389, 2453506, 2422704, 2375235, 2375235, 2375235, 2394700, and 2508571",
      "firm_fei_number": "1000220733",
      "recalling_firm": "Zimmer, Inc.",
      "address_1": "345 E Main St",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46580-2746",
      "additional_info_contact": "574-372-4807",
      "reason_for_recall": "Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info",
      "root_cause_description": "Error in labeling",
      "action": "Zimmer, Inc. sent an \"URGENT MEDICAL DEVICE CORRECTION\" letter dated September 4, 2012 to all affected customers.  The letter identified the product, problem, and actions to be taken by the customers.  A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.",
      "product_quantity": "209",
      "distribution_pattern": "Nationwide Distribution.",
      "openfda": {
        "k_number": [
          "K883212",
          "K023188",
          "K070292",
          "K032659",
          "K062960",
          "K082673",
          "K043542",
          "K201219",
          "K092198",
          "K944752",
          "K983452",
          "K781490",
          "K904870",
          "K994153",
          "K071053",
          "K842233",
          "K761324",
          "K894604",
          "K892398",
          "K021549",
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        ],
        "device_name": "Prosthesis, Hip, Femoral, Resurfacing",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3400",
        "device_class": "2"
      }
    }
  ]
}