{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Independence",
      "address_1": "6701 Rockside Rd Ste 200",
      "reason_for_recall": "Packages labeled as containing 110mm rods may contain 100mm rods.",
      "address_2": "",
      "product_quantity": "10",
      "code_info": "Lot 779C4",
      "center_classification_date": "20180821",
      "distribution_pattern": "The products were distributed to the following US states: OH.",
      "state": "OH",
      "product_description": "Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B    Product Usage:  The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).",
      "report_date": "20180829",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Back 2 Basics Direct LLC",
      "recall_number": "Z-2881-2018",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "80639",
      "termination_date": "20181115",
      "more_code_info": "",
      "recall_initiation_date": "20180629",
      "postal_code": "44131-2316",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}