{ "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": "198048", "product_res_number": "Z-1099-2023", "event_date_initiated": "2022-12-15", "event_date_posted": "2023-02-06", "recall_status": "Open, Classified", "res_event_number": "91493", "product_code": "NDN", "k_numbers": [ "K161114" ], "product_description": "HIGH V+ Spinal Cement System REF T040321K", "code_info": "Model/Part Number: T040321K\nUDI-DI Code: 03760177043084\nBatch Number: 060422382", "firm_fei_number": "3003854593", "recalling_firm": "TEKNIMED SAS", "address_1": "11 zone industrielle montredone rue d apollo", "city": "L'Union", "country": "France", "additional_info_contact": "M. Franck DRUILHET\n512 388 0199", "reason_for_recall": "Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.", "root_cause_description": "Employee error", "action": "On 12/15/2022, the firm contacted customer via a \"URGENT - FIELD SAFETY NOTICE\" informing them of the incorrect expiry date of 2027-02-28 and that the correct expiration date is 2025-02-28.\n\nCustomers are instructed to:\n1. Notify all within their organization or to any organizations where the devices have been transferred.\n2. Isolate the concerned products in their facilities and/or in their customers' ones.\n3. Complete and return by email, within 7 calendar days, the attached statement for the product return, by indicating the concerned quantity by lot and by company to TEKNIMED SAS, Quality Department quality@tekmimed.com\n4. Return, all products clearly identified as recalled products and with the attached statement at the following address: Quality Department TEKNIMED SAS, Z.I. de la Herray, 65500 VIC en BIGORRE (France).\n\nFor questions or assistance - contact Quality Manager at +33 5 34 25 10 60", "product_quantity": "236 systems", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.", "openfda": { "k_number": [ "K072118", "K241775", "K093828", "K150582", "K080108", "K100404", "K220131", "K132817", "K110604", "K133372", "K172214", "K060425", "K231340", "K181262", "K130402", "K133669", "K060300", "K061531", "K211797", "K042691", "K113452", "K112907", "K223294", "K140937", "K113477", "K192403", "K063248", "K162453", "K232842", "K251896", "K043406", "K072496", "K063438", "K192449", "K043593", "K033801", "K103433", "K122533", "K160983", "K240084", "K162283", "K143006", "K122175", "K070351", "K130089", "K072133", "K172871", "K113154", "K141930", "K071927", "K063067", "K093463", "K091606", "K151227", "K090986", "K050864", "K110998", "K161114", "K250637", "K041584", "K102397", "K180700", "K192335", "K042168", "K093419", "K123942", "K130146", "K080873", "K191709", "K110183", "K070527", "K202393", "K132620", "K103064", "K201831", "K141419", "K062424", "K062452", "K150460", "K121876", "K113742", "K162618", "K221697", "K243537", "K093477", "K060148", "K150322", "K053336", "K150607", "K141141", "K163032", "K042947", "K090460", "K153296", "K211238", "K043518", "K103807", "K042415", "K122503", "K090211", "K091234", "K103816", "K100479", "K152557", "K071375", "K090435", "K053180", "K111593" ], "registration_number": [ "3010162973", "1720929", "3015831087", "1824199", "1721504", "3009018440", "1820334", "9610726", "1649518", "1721676", "3018242561", "3013546462", "2953359", "3040335671", "3003120897", "1526439", "9681465", "3004142400", "3010132111", "3008812560", "2031093", "3016842760", "3010120148", "3027518990", "3010071016", "9615788", "3008125983", "3030412764", "3008114965", "9617601", "9617616", "3044905149", "3009421413", "3014003062", "3005827567", "3044858680", "1424263", "3044156918", "9616662", "3003916006", "3009475067", "9615014", "3014725904", "9612420", "3010898856", "3009509485", "1000461041", "3033589330", "3009599228", "3002807112", "3007955117", "3006849754", "2649614", "3009756327", "3015967359", "1724474", "3009417901", "3004598644", "1423662", "3005083075", "8043792", "3013186738", "2648623", "3020163307", "3003678543", "3015309643", "3000270450", "3021638889", "3004464325", "3021566676", "3006946276", "3005180920", "1030489", "3005596514", "3004519921", "2648666", "1123169", "3017155536", "3015399803", "3010178296", "3008215723", "1526534", "3002806603", "9610921", "3010173425", "3008868758", "3006563559", "2530808", "3015225571", "3006406161", "3004099322", "2032098", "3011489618", "3008328679", "3002807314", "3008583793", "2246552", "3004734264", "1928237", "9614841", "3010509633", "3008132398", "3002808022", "3008837339", "3006950086", "2647346", "3018094310", "3043534478", "3005677016", "3005059805", "3012536737", "3008110533", "2029275", "1061927", "3014286836" ], "fei_number": [ "1720929", "3015831087", "1824199", "1721504", "3000215205", "3009018440", "3000203000", "3005846326", "1820334", "1721676", "3018242561", "3013546462", "3040335671", "3003120897", "1526439", "1000306431", "3003058448", "3004142400", "3010132111", "3008812560", "1000123143", "3003110073", "3016842760", "3010120148", "3027518990", "3010071016", "3030412764", "3008114965", "3005568854", "3044905149", "3009421413", "3014003062", "3002807156", "3005827567", "3044858680", "3044156918", "3001236277", "3003916006", "3001236549", "3000335778", "3009475067", "3002808402", "3014725904", "3010898856", "3009509485", "1000461041", "3033589330", "3009599228", "3002807112", "3007955117", "3006849754", "2649614", "3015967359", "3009417901", "3004598644", "3002807113", "3000215273", "3005083075", "3003094851", "3002808269", "3013186738", "3003272754", "2648623", "3020163307", "3003678543", "3015309643", "3000270450", "3021638889", "3004464325", "3021566676", "3006946276", "3005180920", "3005596514", "3002807172", "2648666", "3017155536", "3015399803", "3008215723", "1526534", "3002806603", "3008868758", "3003015552", "3006563559", "3002807091", "3002807036", "3015225571", "3002534070", "3006406161", "3004099322", "3011489618", "3002806724", "3008328679", "3002807314", "1000522098", "3008583793", "2246552", "3004734264", "1000477302", "1928237", "3010509633", "3002808022", "3008837339", "3003854593", "3006950086", "3002807041", "2647346", "3018094310", "3043534478", "3005677016", "3005059805", "3012536737", "3008110533", "3002807038", "3008125983", "3014286836" ], "device_name": "Cement, Bone, Vertebroplasty", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3027", "device_class": "2" } } ] }