{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210214", "product_res_number": "Z-0260-2025", "event_date_initiated": "2024-09-03", "event_date_posted": "2024-10-30", "recall_status": "Open, Classified", "res_event_number": "95424", "product_code": "OWB", "k_numbers": [ "K173736", "K200360" ], "product_description": "Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.", "code_info": "GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027", "firm_fei_number": "3014391847", "recalling_firm": "Trackx Technology Inc", "address_1": "437 Dimmocks Mill Rd Ste 28 437 Dimmocks Mill Rd", "address_2": "Ste 28", "city": "Hillsborough", "state": "NC", "postal_code": "27278-2379", "additional_info_contact": "Frederick Cole\n1-209-4033160", "reason_for_recall": "The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.", "root_cause_description": "Error in labeling", "action": "TrackX Technology issued an Urgent: Medical Device Field Correction notice to its consignees via hand delivery by their sales representatives on 10/01/2024. The notice explained the issue and requested that the notice be provided to all parties to whom the product was distributed. The sales representatives exchanged the affected product for correctly labeled product.", "product_quantity": "82", "distribution_pattern": "NC, VA, FL, PA, NY", "openfda": { "k_number": [ "K201583", "K201172", "K223409", "K002198", "K002016", "K152928", "K092439", "K200218", "K093066", "K191503", "K100102", "K142273", "K201743", "K070123", "K121444", "K162614", "K172180", "K133819", "K203281", "K160455", "K260607", "K153232", "K230787", "K010942", "K130893", "K053279", "K220342", "K120282", "K092004", "K000221", "K171755", "K161563", "K233200", "K163140", "K023178", "K151598", "K060259", "K113027", "K170832", "K202431", "K181943", "K240020", "K181830", "K122457", "K232420", "K252068", "K243884", "K172863", "K993687", "K233107", "K170909", "K051064", "K202547", "K203535", "K222998", "K993037", "K243411", "K111344", "K912448", "K041931", "K132305", "K200074", "K163286", "K211782", "K122644", "K151000", "K182086", "K101833", "K212523", "K200663", "K190768", "K252503", "K170800", 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"1000132370", "3030691709", "3010703925", "3014343100", "3009144915" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }