{
  "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": "81682",
      "product_res_number": "Z-0370-2010",
      "event_date_initiated": "2009-05-28",
      "event_date_posted": "2009-11-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-10-05",
      "res_event_number": "51933",
      "product_code": "NQP",
      "k_numbers": [
        "K073347"
      ],
      "product_description": "Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.",
      "code_info": "All lots.  Lots 60859166, 60859167, 61085708. 60970745, 61024375, 61024376 and 61123514.",
      "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": "800-777-7505",
      "reason_for_recall": "The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter dated 5/20/09 titled \"Urgent Medical Device Correction\" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use.  Users were also advised to ensure the spacer cutter is properly lubricated and is sharp.  For questions, please contact Zimmer Spine at 1-800-777-7505.",
      "product_quantity": "177",
      "distribution_pattern": "Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.",
      "openfda": {
        "k_number": [
          "K101083",
          "K073347",
          "K080963",
          "K060638",
          "K071261",
          "K091944",
          "K073439",
          "K061304",
          "K072321",
          "K182928",
          "K191066",
          "K092234",
          "K043565",
          "K080241",
          "K133164",
          "K101704",
          "K072969",
          "K072685",
          "K203678",
          "K071879",
          "K061774",
          "K031511"
        ],
        "registration_number": [
          "3010160527",
          "3008793310",
          "1526534",
          "3010120135",
          "3009888740",
          "2134285",
          "1824199",
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          "3015207155",
          "3010032903",
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          "3009973336",
          "3003761012",
          "2647346"
        ],
        "fei_number": [
          "3008793310",
          "3002808269",
          "1526534",
          "3003076831",
          "3010120135",
          "3009888740",
          "3002807040",
          "1824199",
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          "3018094310",
          "3004142400",
          "3009217531",
          "3003120897",
          "3004188066",
          "3000717902",
          "3030412764",
          "3011683674",
          "3006846753",
          "1000477302",
          "1000115656",
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          "3005144609",
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          "3010120104",
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          "3010287737",
          "3015207155",
          "3010032903",
          "3005677016",
          "3009973336",
          "3003761012",
          "2647346"
        ],
        "device_name": "Posterior Metal/Polymer Spinal System, Fusion",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3070",
        "device_class": "2"
      }
    }
  ]
}