{ "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": "220295", "product_res_number": "Z-2793-2026", "event_date_initiated": "2026-05-13", "event_date_posted": "2026-07-23", "recall_status": "Open, Classified", "res_event_number": "98967", "product_code": "GWF", "k_numbers": [ "K252842" ], "product_description": "SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System", "code_info": "UDI-DI: 00190376517506.\nSystem Set ID/Patient Interface Serial Number:\n2007716/ DG106225,\n2005498/ DG106220,\n2005490/ DG106230", "firm_fei_number": "2027467", "recalling_firm": "Alphatec Spine, Inc.", "address_1": "1950 Camino Vida Roble", "city": "Carlsbad", "state": "CA", "postal_code": "92008-6505", "additional_info_contact": "760-431-9286", "reason_for_recall": "Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.", "root_cause_description": "Software Design Change", "action": "On 5/13/2026, recall notices were emailed to customers who were advised of the following:\n\n1) Recalling firm has provided replacement SafeOp 3 Systems.\n2) Abstain from using affected devices and return to recalling firm.\n3) Share this notice within your organization or any organization where the affected\ndevice(s) has(have) been transferred.\n4) Fill out the last page of this letter to confirm that you have read this notification\nand have taken all necessary actions, as described in this notification.\n\nIf you have any questions/concerns or require assistance with the recall, please e-mail\nQMSCompliance@atecspine.com or call 1-800-922-1356.", "product_quantity": "3", "distribution_pattern": "US Nationwide distribution in the states of TX, MO, IN.", "openfda": { "k_number": [ "K924723", "K234080", "K072343", "K002773", "K952294", "K912685", "K130346", "K002969", "K051384", "K944547", "K992911", "K843253", "K931923", "K960170", "K923315", "K030526", "K905059", "K082614", "K915652", "K932994", "K090298", "K233292", "K992313", "K094054", "K123843", "K894608", "K860903", "K061113", "K885246", "K862690", "K843464", "K902607", "K062765", "K061639", "K031930", "K230415", "K083371", "K780539", "K020400", "K810560", "K870567", "K962458", "K083124", "K851300", "K051357", "K071969", "K142624", "K040358", "K160280", "K192823", "K894560", "K962455", "K252842", "K900482", "K822744", "K903731", "K032741", "K243982", "K863175", "K822396", "K093304", "K234092", "K112881", "K831896", "K213849", "K871964", "K150220", "K000963", "K162199", 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