{
  "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": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72962",
      "recalling_firm": "OrthoPediatrics Corp",
      "address_1": "2850 Frontier Dr",
      "address_2": "N/A",
      "postal_code": "46582-7001",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.",
      "recall_number": "Z-0622-2016",
      "product_description": "UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw    The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.",
      "product_quantity": "102",
      "reason_for_recall": "Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.",
      "recall_initiation_date": "20151110",
      "center_classification_date": "20160108",
      "termination_date": "20160523",
      "report_date": "20160120",
      "code_info": "Item number; lot; product description    00-1300-1735; 44003; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 35MM.  00-1300-0735; 44601; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM.  00-1300-0740; 44602; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM.  00-1300-0740; 43926; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM.  00-1300-0740; 44252; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM.  00-1300-0745; 43927; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM.  00-1300-0750; 44619; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM.  00-1300-0620; 44623; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 20MM.  00-1300-0640; 44617; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM.  00-1300-0640; 44884; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM.  00-1300-1745; 44005; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 45MM.  00-1300-0635; 44677; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 35MM."
    }
  ]
}