{
  "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": "64624",
      "product_res_number": "Z-0419-2008",
      "event_date_initiated": "2007-09-27",
      "event_date_posted": "2007-12-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-04-30",
      "res_event_number": "44893",
      "product_code": "NJL",
      "k_numbers": [
        "K950010"
      ],
      "product_description": "Depuy P.F.C.  E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650.",
      "code_info": "Lot 81257A.",
      "firm_fei_number": "1818910",
      "recalling_firm": "Depuy Orthopaedics, Inc.",
      "address_1": "700 Orthopaedic Dr",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46582-3994",
      "additional_info_contact": "800-366-8143",
      "reason_for_recall": "An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.",
      "root_cause_description": "Packaging process control",
      "action": "Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07.  The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product.  Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.",
      "product_quantity": "12",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "pma_number": [
          "P830055",
          "P060037"
        ],
        "registration_number": [
          "1724955",
          "1038671",
          "3008812251",
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        "fei_number": [
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          "3002808293",
          "3002808269",
          "2245304",
          "3008868758",
          "3002854251",
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        ],
        "device_name": "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}