{ "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": "216784", "product_res_number": "Z-0896-2026", "event_date_initiated": "2025-11-03", "event_date_posted": "2025-12-11", "recall_status": "Open, Classified", "res_event_number": "97862", "product_code": "ODP", "k_numbers": [ "K203342" ], "product_description": "Brand Name: CONSTRUX\" Mini Ti Spacer System\nProduct Name: CONSTRUX\" Mini Ti Spacer System\nModel/Catalog Number: 37-6005SP\t12mm W X 12mm L, 5mm H, 5 Lordotic\n37-6005SP\t12mm W X 12mm L, 5mm H, 5 Lordotic\n37-6005SP\t12mm W X 12mm L, 5mm H, 5 Lordotic\n37-6006SP\t12mm W X 12mm L, 6mm H, 5 Lordotic\n37-6006SP\t12mm W X 12mm L, 6mm H, 5 Lordotic\n37-6006SP\t12mm W X 12mm L, 6mm H, 5 Lordotic\n37-6007SP\t12mm W X 12mm L, 7mm H, 5 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"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": "40956", "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": [ "K233839", "K223043", "K102449", "K190380", "K252737", "K180590", "K183557", "K150362", "K213980", "K121178", "K181590", "K213755", "K122085", "K132732", "K162694", "K240416", "K231371", "K091088", "K150812", "K111123", "K083425", "K081614", "K252219", "K242195", "K163422", "K200312", "K252240", "K211501", "K181140", "K223731", "K160125", "K162587", "K161809", "K150130", "K100889", "K111264", "K191822", "K180364", "K092540", "K133815", "K250764", "K250335", "K160154", "K221162", "K133653", "K142450", 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Cervical", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3080", "device_class": "2" } } ] }