{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Warsaw",
      "address_1": "56 E Bell Dr",
      "reason_for_recall": "The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.",
      "address_2": "",
      "product_quantity": "Not known",
      "code_info": "All lots",
      "center_classification_date": "20180326",
      "distribution_pattern": "Worldwide and US of Indiana and country of the Republic of Korea.",
      "state": "IN",
      "product_description": "AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255\tNAIL TIB DYN 08X25.5 - STERILE  800508270\tNAIL TIB DYN 08X27.0 - STERILE  800508285\tNAIL TIB DYN 08X28.5 - STERILE  800508300\tNAIL TIB DYN 08X30.0 - STERILE  800508315\tNAIL TIB DYN 08X31.5 - STERILE  800508330\tNAIL TIB DYN 08X33.0 - STERILE  800508345\tNAIL TIB DYN 08X34.5 - STERILE  800508360\tNAIL TIB DYN 08X36.0 - STERILE  800508375\tNAIL TIB DYN 08X37.5 - STERILE  800508390\tNAIL TIB DYN 08X39.0 - STERILE  800508405\tNAIL TIB DYN 08X40.5 - STERILE  800508420\tNAIL TIB DYN 08X42.0 - STERILE  800509255\tNAIL TIB DYN 09X25.5 - STERILE  800509270\tNAIL TIB DYN 09X27.0 - STERILE  800509285\tNAIL TIB DYN 09X28.5 - STERILE  800509300\tNAIL TIB DYN 09X30.0 - STERILE  800509315\tNAIL TIB DYN 09X31.5 - STERILE  800509330\tNAIL TIB DYN 09X33.0 - STERILE  800509345\tNAIL TIB DYN 09X34.5 - STERILE  800509360\tNAIL TIB DYN 09X36.0 - STERILE  800509375\tNAIL TIB DYN 09X37.5 - STERILE  800509390\tNAIL TIB DYN 09X39.0 - STERILE  800509405\tNAIL TIB DYN 09X40.5 - STERILE  800509420\tNAIL TIB DYN 09X42.0 - STERILE  800510255\tNAIL TIB DYN 10X25.5 - STERILE  800510270\tNAIL TIB DYN 10X27.0 - STERILE  800510285\tNAIL TIB DYN 10X28.5 - STERILE  800510300\tNAIL TIB DYN 10X30.0 - STERILE  800510315\tNAIL TIB DYN 10X31.5 - STERILE  800510330\tNAIL TIB DYN 10X33.0 - STERILE  800510345\tNAIL TIB DYN 10X34.5 - STERILE  800510360\tNAIL TIB DYN 10X36.0 - STERILE  800510375\tNAIL TIB DYN 10X37.5 - STERILE  800510390\tNAIL TIB DYN 10X39.0 - STERILE  800510405\tNAIL TIB DYN 10X40.5 - STERILE  800510420\tNAIL TIB DYN 10X42.0 - STERILE  800511270\tNAIL TIB DYN 11X27.0 - STERILE  800511285\tNAIL TIB DYN 11X28.5 - STERILE  800511300\tNAIL TIB DYN 11X30.0 - STERILE  800511330\tNAIL TIB DYN 11X33.0 - STERILE  800511345\tNAIL TIB DYN 11X34.5 - STERILE  800511360\tNAIL TIB DYN 11X36.0 - STERILE  800511375\tNAIL TIB DYN 11X37.5 - STERILE  800511390\tNAIL TIB DYN 11X39.0 - STERILE  800511405\tNAIL TIB DYN 11X40.5 - STERILE  800511420\tNAIL TIB DYN 11X42.0 - STERILE  800512270\tNAIL TIB DYN 12X27.0 - STERILE  800512285\tNAIL TIB DYN 12X28.5 - STERILE  800512300\tNAIL TIB DYN 12X30.0 - STERILE  800512315\tNAIL TIB DYN 12X31.5 - STERILE  800512330\tNAIL TIB DYN 12X33.0 - STERILE  800512345\tNAIL TIB DYN 12X34.5 - STERILE  800512360\tNAIL TIB DYN 12X36.0 - STERILE  800512375\tNAIL TIB DYN 12X37.5 - STERILE  800512390\tNAIL TIB DYN 12X39.0 - STERILE  800512405\tNAIL TIB DYN 12X40.5 - STERILE  800512420\tNAIL TIB DYN 12X42.0 - STERILE  800513285\tNAIL TIB DYN 13X28.5 - STERILE  800513300\tNAIL TIB DYN 13X30.0 - STERILE  800513315\tNAIL TIB DYN 13X31.5 - STERILE  800513330\tNAIL TIB DYN 13X33.0 - STERILE  800513345\tNAIL TIB DYN 13X34.5 - STERILE  800513360\tNAIL TIB DYN 13X36.0 - STERILE  800513375\tNAIL TIB DYN 13X37.5 - STERILE  800513390\tNAIL TIB DYN 13X39.0 - STERILE  800513405\tNAIL TIB DYN 13X40.5 - STERILE  800513420\tNAIL TIB DYN 13X42.0 - STERILE    Product Usage:  A rod, when inserted into the intramedullary canal of the tibia, acts as an immobilization device to hold ends of a fractured bone in position.",
      "report_date": "20180404",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer Biomet, Inc.",
      "recall_number": "Z-1196-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "79409",
      "termination_date": "20190402",
      "more_code_info": "",
      "recall_initiation_date": "20180206",
      "postal_code": "46582-6989",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}