{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196726",
      "product_res_number": "Z-0277-2023",
      "event_date_initiated": "2022-09-12",
      "event_date_posted": "2022-11-22",
      "recall_status": "Open, Classified",
      "res_event_number": "91098",
      "product_code": "OSN",
      "k_numbers": [
        "K151881"
      ],
      "product_description": "Orthex Large Bone Shoulder Bolt, model no. AS-17",
      "code_info": "UDI-DI: 00841132143155\nLots:\n921052140-E\t922000760-E\t922023360-E\t922023370-E\t922038571-E\t922038581-E\t922038591-E",
      "firm_fei_number": "3006460162",
      "recalling_firm": "OrthoPediatrics Corp",
      "address_1": "2850 Frontier Dr",
      "city": "Warsaw",
      "state": "IN",
      "postal_code": "46582-7001",
      "additional_info_contact": "Mallory Trusty\n574-268-6379",
      "reason_for_recall": "Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On September 12, 2022, the firm notified distributors of the recall. Distributors were asked to notify and retrieve affected devices from end users.\n\nAffected product must be returned to OrthoPediatrics. Replacement product will be provided. Customers should contact customer service to arrange return of the affected product.\n\nCustomers who have patients in frames should be made aware of the possibility of Bolt breakage and continue monitoring their patients.\n\nAny questions regarding this recall can be directed to Joel Batts, Senior VP of Clinical and Regulatory Affairs, at OrthoPediatrics at jbatts@orthopediatrics.com or 574-367-5396.",
      "product_quantity": "1354 (594 US)",
      "distribution_pattern": "Domestic distribution to\n\nForeign distribution to",
      "openfda": {
        "k_number": [
          "K140550",
          "K253764",
          "K221792",
          "K180539"
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        "fei_number": [
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        "device_name": "Software For Diagnosis/Treatment",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3030",
        "device_class": "2"
      }
    }
  ]
}