{
  "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": "2026-04-15",
    "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": "77554",
      "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 - USA (nationwide) Distribution to the states of :  AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of :  Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.",
      "recall_number": "Z-3115-2017",
      "product_description": "Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883.    The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.",
      "product_quantity": "84 units",
      "reason_for_recall": "The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.",
      "recall_initiation_date": "20170626",
      "center_classification_date": "20170911",
      "termination_date": "20210616",
      "report_date": "20170920",
      "code_info": "Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883."
    }
  ]
}