{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216782", "product_res_number": "Z-0894-2026", "event_date_initiated": "2025-11-03", "event_date_posted": "2025-12-11", "recall_status": "Open, Classified", "res_event_number": "97862", "product_code": "OUR", "k_numbers": [ "K200696" ], "product_description": "Brand Name: FIREBIRD\" SI Fusion System\nProduct Name: FIREBIRD\" SI Fusion System\nModel/Catalog Number: 18-1025SP\t11mm X 25mm FIREBIRD SI Screw;\n18-1030SP\t11mm X 30mm FIREBIRD SI Screw;\n18-1035SP\t11mm X 35mm FIREBIRD SI Screw;\n18-1040SP\t11mm X 40mm FIREBIRD SI Screw;\n18-1045SP\t11mm X 45mm FIREBIRD SI Screw;\n18-1050SP\t11mm X 50mm FIREBIRD SI Screw;\n18-1055SP\t11mm X 55mm FIREBIRD SI Screw;\n18-1060SP\t11mm X 60mm FIREBIRD SI Screw;\n18-1065SP\t11mm X 65mm FIREBIRD SI Screw;\n18-1070SP\t11mm X 70mm FIREBIRD SI Screw;\n18-2025SP\t12mm X 25mm FIREBIRD SI Screw;\n18-2030SP\t12mm X 30mm FIREBIRD SI Screw;\n18-2035SP\t12mm X 35mm FIREBIRD SI Screw;\n18-2040SP\t12mm X 40mm FIREBIRD SI Screw;\n18-2045SP\t12mm X 45mm FIREBIRD SI Screw;\n18-2050SP\t12mm X 50mm FIREBIRD SI Screw;\n18-2055SP\t12mm X 55mm FIREBIRD SI Screw;\n18-2060SP\t12mm X 60mm FIREBIRD SI Screw;\n18-2065SP\t12mm X 65mm FIREBIRD SI Screw;\n18-2070SP\t12mm X 70mm FIREBIRD SI Screw", "code_info": "Lot Code: All Lots/ UDI: 18-1025SP\t18257200140084;\n18-1030SP\t18257200140091;\n18-1035SP\t18257200140107;\n18-1040SP\t18257200140114;\n18-1045SP\t18257200140275;\n18-1050SP\t18257200140121;\n18-1055SP\t18257200140138;\n18-1060SP\t18257200140145;\n18-1065SP\t18257200140152;\n18-1070SP\t18257200140169;\n18-2025SP\t18257200140176;\n18-2030SP\t18257200140183;\n18-2035SP\t18257200140190;\n18-2040SP\t18257200140206;\n18-2045SP\t18257200140213;\n18-2050SP\t18257200140220;\n18-2055SP\t18257200140237;\n18-2060SP\t18257200140244;\n18-2065SP\t18257200140251;\n18-2070SP\t18257200140268", "firm_fei_number": "2183449", "recalling_firm": "Orthofix U.S. LLC", "address_1": "3451 Plano Pkwy", "city": "Lewisville", "state": "TX", "postal_code": "75056-9453", "additional_info_contact": "Orthofix Field Actions\n214-937-2000", "reason_for_recall": "Labeling contains claims that are not consistently present.", "root_cause_description": "Device Design", "action": "On November 3, 2025 Orthofix issued a recall notification via Email to affected consignees. In addition to informing consignees about the recall , Orthofix ask consignees to take the following actions:\n\n1. Orthofix is removing claims regarding Nanovate Technology in materials, including but not limited to Operative Techniques, Product Brochures, Medical Education Documents, and the Orthofix website.\n\n2. No product return is being requested. You may continue to use the product.\n\n3. Distribute this Notice to all relevant personnel within your organization.\n\n4. Forward this Notice to other organization or facilities where affected products may have been transferred.\n\n5. Acknowledge this Notice and return the completed receipt form to fieldactions@orthofix.com", "product_quantity": "19431", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.", "openfda": { "k_number": [ "K173752", "K230689", "K200868", "K203138", "K160652", "K190025", "K232149", "K240505", "K253094", "K170475", "K200696", "K233508", "K180818", "K182983", "K222448", "K181881", "K130092", "K232605", "K161755", "K252834", "K161210", "K150714", "K080398", "K250403", "K193083", "K231841", "K212903", "K153656", "K203503", "K213590", "K253488", "K243838", "K122074", "K152681", "K233241", "K221047", "K243835", "K221050", "K250001", "K241464", "K151462", "K171595", "K201538", "K191748", "K141549", "K210402", 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