{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Goteborg",
      "state": "",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96047",
      "recalling_firm": "Nobel Biocare",
      "address_1": "Vastra Hamngatan 1",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.",
      "recall_number": "Z-1101-2025",
      "product_description": ". Nobel Biocare N1 TiUltra TCC RP 4.0x9mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm  . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm    Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous  dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function",
      "product_quantity": "1,558 units (90 units - U.S.)",
      "reason_for_recall": "Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.",
      "recall_initiation_date": "20250110",
      "center_classification_date": "20250205",
      "report_date": "20250212",
      "code_info": "Nobel Biocare N1 TiUltra TCC RP 4.0x 9mm Catalog Number: 300861 UDI-DI code:  07332747161731 Lot Numbers: 12253672 12253673  Nobel Biocare N1 TiUltra TCC RP 4.0x11mm Catalog Number: 300862 UDI-DI code:  07332747161748 Lot Numbers: 12253448 12254209  Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Catalog Number: 300863 UDI-DI code: 07332747161755 Lot Numbers: 12253620 12254213",
      "more_code_info": ""
    }
  ]
}