{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Carlsbad",
      "address_1": "1900 Aston Ave",
      "reason_for_recall": "The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.",
      "address_2": "",
      "product_quantity": "356 units",
      "code_info": "Lot numbers 63563072, 63572755, 63583270, and 63755802",
      "center_classification_date": "20171221",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.",
      "state": "CA",
      "product_description": "Zimmer Dental GemLock RHD2.5 Hex Driver.  The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.     Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.",
      "report_date": "20171227",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer Dental Inc",
      "recall_number": "Z-0279-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "78321",
      "termination_date": "20190313",
      "more_code_info": "",
      "recall_initiation_date": "20171011",
      "postal_code": "92008-7308",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}