{
  "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:  333152  333152  338845  341493  347126  351531  355537  359848  364534  364971  369364  370407  378060  380152",
      "center_classification_date": "20210311",
      "distribution_pattern": "US Nationwide distribution.",
      "state": "MI",
      "product_description": "CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - 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-1225-2021",
      "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"
    }
  ]
}