{
  "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,
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  },
  "results": [
    {
      "cfres_id": "167610",
      "product_res_number": "Z-0394-2019",
      "event_date_initiated": "2018-08-22",
      "event_date_created": "2018-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-06-17",
      "res_event_number": "81072",
      "product_code": "GXN",
      "k_numbers": [
        "K031034"
      ],
      "product_description": "Biomet Microfixation RapidFlap  System, 12MM RapidFlap SpinDown Clamp, 12 Pack\nRef Number: 75-1020-12\tUsed for the re-attachment of the bone flap after a craniotomy.",
      "code_info": "Lot Expiry Date Before: 09/18/2023",
      "firm_fei_number": "1825034",
      "recalling_firm": "Zimmer Biomet, Inc.",
      "address_1": "56 E Bell Dr",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46582-6989",
      "additional_info_contact": "411 Technical Services\n574-371-3071",
      "reason_for_recall": "Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.",
      "root_cause_description": "Process control",
      "action": "Zimmer Biomet conducted recall to the consumer/user level, including any intermediate wholesale or retail consignees. Distributors notified initially via email on 8/22/18. The firm expanded the recall on 10/5/18 to include all lots with lot expiry before 09/18/2023,  letters issued via email and FedEx to Distributors/ Risk Managers/Surgeons.\n\nLetter identifies issue and requesting removing and return of product.\nSurgeons will be provided with a letter that identifies the issue and their responsibilities, which include:\n- Following any specified patient monitoring instructions\n- Returning Certificate of Acknowledgment to Zimmer Biomet.\nHospital risk managers will be provided with a letter identifying the issue.\nQuestions or concerns after reviewing this notice, please call customer service at 907-741-4400 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to  Benjamin.Blystone@zimmerbiomet.com .",
      "product_quantity": "11736 units",
      "distribution_pattern": "Worldwide distribution:  US Nationwide,  \nCanada\nArgentina\nAustralia\nBelgium\nBrazil\nChile\nColombia\nCosta Rica\nCzech Republic\nDominican Republic\nEcuador\nFinland\nFrance\nChina\nEcuador\nGermany\nGreece\nHong Kong\nIndonesia\nItaly\nJapan\nJordan\nKorea\nLebanon\nMalaysia\nNetherland\nParaguay\nPeru\nSingapore\nSouth Africa\nSpain\nSweden\nSwitzerland\nThailand\nTrinidad and Tobago\nTurkey\nUnited Arab Emirates\nUnited Kingdom\nUruguay\nVietnam",
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        "device_name": "Plate, Cranioplasty, Preformed, Non-Alterable",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5330",
        "device_class": "2"
      }
    }
  ]
}