{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Westlake Village",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83518",
      "recalling_firm": "Implant Direct Sybron Manufacturing, LLC",
      "address_1": "3050 E Hillcrest Dr",
      "address_2": "N/A",
      "postal_code": "91362-3171",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide including  the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.",
      "recall_number": "Z-0018-2020",
      "product_description": "ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile.  The mislabeled model/part number on the vial cap is 835216.    The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.",
      "product_quantity": "22 vials",
      "reason_for_recall": "Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.",
      "recall_initiation_date": "20180808",
      "center_classification_date": "20191001",
      "termination_date": "20191007",
      "report_date": "20191009",
      "code_info": "Lot number 110350"
    }
  ]
}