{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220337", "product_res_number": "Z-2355-2026", "event_date_initiated": "2026-05-11", "event_date_posted": "2026-06-08", "recall_status": "Open, Classified", "res_event_number": "98978", "product_code": "JDR", "k_numbers": [ "K161426" ], "product_description": "NeoSpan SuperElastic Compression Staple w/Instruments \nCatalog Number and Product Name\nT50 SN010\tNeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10\nUDI-DI Code: 00817906020083\n\nT50 SN012\tNeoSpan SuperElastic Compression Staple w/Instruments, Size 12x12x12\nUDI-DI Code: 00817906020090\n\nT50 SN020\tNeoSpan SuperElastic Compression Staple w/Instruments, Size 20x20x20\nUDI-DI Code: 00817906020151\n\nT50 SN110\tNeoSpan SuperElastic Compression Staple w/Instruments, Size 10x15x13\nUDI-DI Code: 00817906020113\n\nT50 SN115\tNeoSpan SuperElastic Compression Staple w/Instruments, Size 15Wx15x15\nUDI-DI Code: 00817906020137\n\nT50 SN118\tNeoSpan SuperElastic Compression Staple w/Instruments, Size 18x14x14\nUDI-DI Code: 00810021861364\n\nSingle/multiple component metallic bone fixation appliances and accessories\nThe In2Bones USA NeoSpan\" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.", "code_info": "Catalog No.\tLot Code\nT50 SN010\t1962242\n\t1964665\n\t2054541\n\t2039361\nT50 SN012\t1963511\nT50 SN020\t1971252\n\t1990642\n\t2027441\nT50 SN110\t1971241\nT50 SN115\t19647210\nT50 SN118\t1990631", "firm_fei_number": "3011580264", "recalling_firm": "In2bones USA, LLC", "address_1": "7750a Trinity Rd", "city": "Cordova", "state": "TN", "postal_code": "38018-2722", "reason_for_recall": "Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.", "root_cause_description": "Process control", "action": "On 05/11/20206, the firm emailed an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter to customers informing them that In2Bones USA LLC (In2Bones), a CONMED Corporation owned company, is voluntarily recalling NeoSpan SuperElastic Compression Staples with Instruments. In2Bones was notified by it s supplier of an issue affecting certain lots of the NeoSpan SuperElastic Compression Staples with Instruments, in which the Magnetic Resonance (MR) Conditional symbol was missing at the packaging level.\n\nCustomers are instructed to:\n1. Consult the IFU for MR Conditional symbology and MR Conditional use criteria. Copies of the Instructions for Use for the NeoSpan SuperElastic Compression Staple with Instruments are available electronically at eifu.conmed.com/eifu.\n2. follow the instructions below and respond directly to CONMED with their acknowledgement for the NeoSpan SuperElastic Compression Staple w/Instruments.\nStep 1: Please review your inventory for any of the devices with the affected lot numbers listed in \nTable 1. We ask that you contact all departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately.\n\nStep 2a: If you HAVE inventory of any of the affected lot numbers in Table 1.\nPlease do not return any devices as this is a Medical Device Correction; not a removal.\n\nStep 2b: If the device has been implanted, update the patient chart using the provided IFU.\n\nComplete the medical device recall response form (Attachment I) and acknowledge it via email to neospan2026@conmed.com.\n\nThe affected products were distributed from August 12, 2025, through January 12, 2026.\n\nFor questions - contact the Field Action Support Team at 1-800-448-6506 (8:00am to 7:00pm ET, Monday through Friday) or email neospan2026@conmed.com.", "product_quantity": "306 kits", "distribution_pattern": "U.S.: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MD, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WI\n\nO.U.S.: Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, United Kingdom,", "openfda": 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