{
  "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": {
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      "cfres_id": "65507",
      "product_res_number": "Z-0307-2008",
      "event_date_initiated": "2007-09-19",
      "event_date_posted": "2008-01-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-03-10",
      "res_event_number": "45461",
      "product_code": "JDK",
      "k_numbers": [
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      ],
      "product_description": "VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile; Encore Orthopedics, Austin, TX  78758.",
      "code_info": "Lot #: U102.",
      "firm_fei_number": "1000116912",
      "recalling_firm": "Encore Medical, Lp",
      "address_1": "9800 Metric Blvd",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78758",
      "additional_info_contact": "512-834-6235",
      "reason_for_recall": "Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)",
      "root_cause_description": "Labeling Change Control",
      "action": "The recalling firm notified consignees of its recall via an Urgent Device Recall letter on 09/19/07.  Consignees notified of a labeling error regarding device usage and were told they would be notified by a customer service rep to facilitate return of the recalled devices.",
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      "distribution_pattern": "Nationwide: including direct accounts in CO, KS and TX.",
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