{
  "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": "Ongoing",
      "city": "Marietta",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79889",
      "recalling_firm": "Spinal Elements",
      "address_1": "1755 W Oak Pkwy",
      "address_2": "N/A",
      "postal_code": "30062-2260",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Distribution to the states of : FL, GA, NC, PA and CO",
      "recall_number": "Z-1912-2018",
      "product_description": "AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11    The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The ¿LIF  features a self-locking expansion mechanism that is infinitely adjustable, along with a bullet nose design for minimal impaction and ease of insertion. The ¿LIF  is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences",
      "product_quantity": "19 units",
      "reason_for_recall": "Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.",
      "recall_initiation_date": "20180416",
      "center_classification_date": "20180523",
      "report_date": "20180530",
      "code_info": "Lot Number 140760"
    }
  ]
}