{
  "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:  332506  338836  342573  344105  350523  361814  364756  366089  369339  379083",
      "center_classification_date": "20210311",
      "distribution_pattern": "US Nationwide distribution.",
      "state": "MI",
      "product_description": "CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - 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-1219-2021",
      "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"
    }
  ]
}