{
  "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 - NON-STERILE; Item numbers: 810508255\tNAIL TIB DYN 08 X 25.5  810508270\tNAIL TIB DYN 08 X 27.0  810508285\tNAIL TIB DYN 08 X 28.5  810508300\tNAIL TIB DYN 08 X 30.0  810508315\tNAIL TIB DYN 08 X 31.5  810508330\tNAIL TIB DYN 08 X 33.0  810508345\tNAIL TIB DYN 08 X 34.5  810508360\tNAIL TIB DYN 08 X 36.0  810508375\tNAIL TIB DYN 08 X 37.5  810508390\tNAIL TIB DYN 08 X 39.0  810508405\tNAIL TIB DYN 08 X 40.5  810508420\tNAIL TIB DYN 08 X 42.0  810509255\tNAIL TIB DYN 09 X 25.5  810509270\tNAIL TIB DYN 09 X 27.0  810509285\tNAIL TIB DYN 09 X 28.5  810509300\tNAIL TIB DYN 09 X 30.0  810509315\tNAIL TIB DYN 09 X 31.5  810509330\tNAIL TIB DYN 09 X 33.0  810509345\tNAIL TIB DYN 09 X 34.5  810509360\tNAIL TIB DYN 09 X 36.0  810509375\tNAIL TIB DYN 09 X 37.5  810509390\tNAIL TIB DYN 09 X 39.0  810509405\tNAIL TIB DYN 09 X 40.5  810509420\tNAIL TIB DYN 09 X 42.0  810510255\tNAIL TIB DYN 10 X 25.5  810510270\tNAIL TIB DYN 10 X 27.0  810510285\tNAIL TIB DYN 10 X 28.5  810510300\tNAIL TIB DYN 10 X 30.0  810510315\tNAIL TIB DYN 10 X 31.5  810510330\tNAIL TIB DYN 10 X 33.0  810510345\tNAIL TIB DYN 10 X 34.5  810510360\tNAIL TIB DYN 10 X 36.0  810510375\tNAIL TIB DYN 10 X 37.5  810510390\tNAIL TIB DYN 10 X 39.0  810510405\tNAIL TIB DYN 10 X 40.5  810510420\tNAIL TIB DYN 10 X 42.0  810511255\tNAIL TIB DYN 11 X 25.5  810511270\tNAIL TIB DYN 11 X 27.0  810511285\tNAIL TIB DYN 11 X 28.5  810511300\tNAIL TIB DYN 11 X 30.0  810511315\tNAIL TIB DYN 11 X 31.5  810511330\tNAIL TIB DYN 11 X 33.0  810511345\tNAIL TIB DYN 11 X 34.5  810511360\tNAIL TIB DYN 11 X 36.0  810511375\tNAIL TIB DYN 11 X 37.5  810511390\tNAIL TIB DYN 11 X 39.0  810511405\tNAIL TIB DYN 11 X 40.5  810511420\tNAIL TIB DYN 11 X 42.0  810512270\tNAIL TIB DYN 12 X 27.0  810512285\tNAIL TIB DYN 12 X 28.5  810512300\tNAIL TIB DYN 12 X 30.0  810512315\tNAIL TIB DYN 12 X 31.5  810512330\tNAIL TIB DYN 12 X 33.0  810512345\tNAIL TIB DYN 12 X 34.5  810512360\tNAIL TIB DYN 12 X 36.0  810512375\tNAIL TIB DYN 12 X 37.5  810512390\tNAIL TIB DYN 12 X 39.0  810512405\tNAIL TIB DYN 12 X 40.5  810512420\tNAIL TIB DYN 12 X 42.0  810513255\tNAIL TIB DYN 13 X 25.5  810513285\tNAIL TIB DYN 13MM X 28.5CM  810513300\tNAIL TIB DYN 13MMX30.0 CM  810513315\tNAIL TIB DYN 13MM X 31.5 CM  810513330\tNAIL TIB DYN 13 X 33.0  810513345\tNAIL TIB DYN 13MM X 34.5 CM  810513360\tNAIL TIB DYN 13 X 36.0 MM  810513375\tNAIL TIB DYN 13MM X 37.5 CM  810513390\tNAIL TIB DYN 13MMX39.0CM  810513405\tNAIL TIB DYN 13MM X 40.5 CM  810513420\tNAIL TIB DYN 13MM X 42 CM      Product Usage:  A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.",
      "report_date": "20180404",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer Biomet, Inc.",
      "recall_number": "Z-1197-2018",
      "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"
    }
  ]
}