{
  "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": "Hummelstown",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80499",
      "recalling_firm": "New Era Orthopaedics, LLc",
      "address_1": "1214 Research Blvd Ste 1019",
      "address_2": "N/A",
      "postal_code": "17036-9153",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "2 distributors in CO and TX.",
      "recall_number": "Z-2604-2018",
      "product_description": "Modera Modular Pedicle Screw System   Shank Insertion Instrument, 3-107-07",
      "product_quantity": "6 pieces",
      "reason_for_recall": "This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.",
      "recall_initiation_date": "20170213",
      "center_classification_date": "20180803",
      "termination_date": "20181107",
      "report_date": "20180815",
      "code_info": "11125"
    }
  ]
}