{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Warsaw",
      "address_1": "2850 Frontier Dr",
      "reason_for_recall": "The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.",
      "address_2": "",
      "product_quantity": "7 units shipped",
      "code_info": "Part Number:. 00-0903-2634 and lot number 009U2",
      "center_classification_date": "20131114",
      "distribution_pattern": "Worldwide Distribution - US including Michigan and the countries of  Ireland and Australia",
      "state": "IN",
      "product_description": "3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM    The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.",
      "report_date": "20131120",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "OrthoPediatrics Corp",
      "recall_number": "Z-0276-2014",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "66450",
      "termination_date": "20131226",
      "more_code_info": "",
      "recall_initiation_date": "20130926",
      "postal_code": "46582-7001",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}