{
  "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": [
    {
      "country": "United States",
      "city": "Marquette",
      "address_1": "375 River Park Cir",
      "reason_for_recall": "Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision",
      "address_2": "",
      "product_quantity": "",
      "code_info": "Batch Number:  330976  330977  330978  338832  343961  344101  350518  350519  356799  358457  361805  361806  364750  367806  369337  370395  377189  379019  380051  380052  380053  380054  380055  380056  380687  380688  380689",
      "center_classification_date": "20210311",
      "distribution_pattern": "US Nationwide distribution.",
      "state": "MI",
      "product_description": "CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).",
      "report_date": "20210317",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)",
      "recall_number": "Z-1215-2021",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "87251",
      "more_code_info": "",
      "recall_initiation_date": "20210115",
      "postal_code": "49855-1781",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}