{
  "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": "121770",
      "product_res_number": "Z-0080-2014",
      "event_date_initiated": "2013-08-30",
      "event_date_posted": "2013-10-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-09-25",
      "res_event_number": "65799",
      "product_code": "NJL",
      "pma_numbers": [
        "P060037"
      ],
      "product_description": "NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)",
      "code_info": "Part Number Range:005930-010/080-01/02",
      "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": "800-613-6131",
      "reason_for_recall": "The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.",
      "root_cause_description": "Package design/selection",
      "action": "August 30, 2013 Urgent Recall Notices were sent to  Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification.    The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives.   Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.",
      "product_quantity": "3475",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.",
      "openfda": {
        "pma_number": [
          "P830055",
          "P060037"
        ],
        "registration_number": [
          "1724955",
          "1038671",
          "3008812251",
          "1827096",
          "1219655",
          "3011683674",
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          "8010379",
          "1526534",
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          "8043792",
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          "1828464",
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          "3008868758",
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        ],
        "fei_number": [
          "1038671",
          "1827096",
          "1828464",
          "1219655",
          "3011683674",
          "1220477",
          "1526534",
          "3007539489",
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          "3015542154",
          "1000306340",
          "1218882",
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          "3015207155",
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          "1000199976",
          "1000220733",
          "3015516266",
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          "3002808293",
          "3002808269",
          "2245304",
          "3008868758",
          "3002854251",
          "3009116370"
        ],
        "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}