{ "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": "219927", "product_res_number": "Z-2213-2026", "event_date_initiated": "2026-04-23", "event_date_posted": "2026-05-20", "recall_status": "Open, Classified", "res_event_number": "98835", "product_code": "OVD", "k_numbers": [ "K211769" ], "product_description": "OneLIF Interbody Cage (REF/Description):\n010-107-1007/Small 7 Degree 10mm X 7mm,\n010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique,\n010-107-1209/Small 7 Degree 12mm X 9mm,\n010-107-1411/Small 7 Degree 14mm X 11mm,\n010-107-1613/Small 7 Degree 16mm X 13mm,\n010-113-1006/Small, 13 Degree 10mm X 6mm,\n010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique,\n010-113-1208/Small 13 Degree 12mm X 8mm,\n010-113-1410/Small 13 Degree 14mm X 10mm,\n010-113-1612/Small 13 Degree 16mm X 12mm,\n010-119-1407/19 Degree 14mm X 7mm,\n010-119-1609/Small 19 Degree 16mm X 9mm,\n010-119-1811/Small 19 Degree 18mm X 11mm,\n010-125-1606/Small 25 Degree 16mm X 6mm,\n010-125-1808/Small 25 Degree 18mm X 8mm,\n010-207-1007/Medium 7 Degree 10mm X 7mm,\n010-207-1007-2/Medium 7 Degree 10mm X 7mm - Oblique,\n010-207-1209/Medium 7 Degree 12mm X 9mm,\n010-207-1411/Medium 7 Degree 14mm X 11mm,\n010-207-1613/Medium 7 Degree 16mm X 13mm,\n010-213-1206/Medium 13 Degree 12mm X 6mm,\n010-213-1408/Medium 13 Degree 14mm X 8mm,\n010-213-1610/Medium 13 Degree 16mm X 10mm,\n010-213-1812/Medium 13 Degree 18mm X 12mm,\n010-219-1406/Medium 19 Degree 14mm X 6mm,\n010-219-1608/Medium 19 Degree 16mm X 8mm,\n010-219-1810/Medium 19 Degree 18mm X 10mm,\n010-225-1807/Medium 25 Degree 18mm X 7mm,\n010-225-2009/Medium 25 Degree 20mm X 9mm,\n010-307-1006/Large 7 Degree,10mm X 6mm,\n010-307-1006-2/Large 7 Degree 10mm X 6mm - Oblique,\n010-307-1208/ Large 7 Degree 12mm X 8mm,\n010-307-1410/Large 7 Degree 14mm X 10mm,\n010-307-1612/Large 7 Degree 16mm X 12mm,\n010-313-1205/Large 13 Degree 12mm X 5mm,\n010-313-1407/Large 13 Degree 14mm X 7mm,\n010-313-1609/Large 13 Degree 16mm X 9mm,\n010-313-1811/Large 13 Degree 18mm X 11mm,\n010-313-2013/Large 13 Degree 20mm X 13mm,\n010-319-1606/Large 19 Degree 16mm X 6mm,\n010-319-1808/ Large 19 Degree 18mm X 8mm,\n010-319-2010/ Large 19 Degree 20mm X 10mm,\n010-325-2007/Large 25 Degree 20mm X 7mm,\n010-325-2209/ Large 25 Degree 22mm X 9mm,\n\nImplant Kits containing OneLIF Interbody Cages, Name/Kit Family:\nKit-OneLIF-10 mm (716)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (717)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (718)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (719)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (722)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (723)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (724)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (733)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (734)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (737)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (738)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (746)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (751)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (761)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (762)/Kit-OneLIF-10 mm,\nKit-OneLIF-10 mm (787)/Kit-OneLIF-10 mm,\nKit-OneLIF- IMPOneLIF Implant Kit (701)/Kit-OneLIF-IMP - OneLIF Implant Kit,\nKit-OneLIF-IMP - OneLIF Implant Kit (702)/Kit-OneLIF-IMP - OneLIF Implant Kit,\nKit-OneLIF-IMP - OneLIF Implant Kit (703) NL/Kit-OneLIF-IMP - OneLIF Implant Kit,\nKit-OneLIF-IMP - OneLIF Implant Kit (704)/Kit-OneLIF-IMP - OneLIF Implant Kit,\nKit-OneLIF-IMP - OneLIF Implant Kit (705)/Kit-OneLIF-IMP - OneLIF Implant Kit,\nKit-OneLIF-IMP - OneLIF Implant Kit (706)/Kit-OneLIF-IMP - OneLIF Implant Kit,\nKit-OneLIF-IMP - OneLIF Implant Kit (708)/Kit-OneLIF-IMP - OneLIF Implant Kit,\nKit-OneLIF-IMP - OneLIF Implant Kit (709)/Kit-OneLIF-IMP - OneLIF Implant Kit,", "code_info": "REF/UDI-DI/ Cage Lots:\n010-107-1007/G07001010710070/ 103003, 105701, 118001, 129301;\n010-107-1007-2/G070010107100720/ 114301, 117509, 128703;\n010-107-1209/G07001010712090/ 102714, 105702, 117501;\n010-107-1411/G07001010714110/ 103019, 105703;\n010-107-1613/G07001010716130/ 103020, 105704, 127701;\n010-113-1006/G07001011310060/ 103021, 105705, 118002, 129801;\n010-113-1006-2/G070010113100620/ 117510, 127716, 114302;\n010-113-1208/G07001011312080/ 103022, 105706, 117502, 126902;\n010-113-1410/G07001011314100/ 102715, 105707, 127702;\n010-113-1612/G07001011316120/ 103023, 105708, 127703;\n010-119-1407/G07001011914070/ 103024, 105709, 125101, 128701;\n010-119-1609/G07001011916090/ 102716, 105710, 127001;\n010-119-1811/G07001011918110/ 103025, 105711, 127003;\n010-125-1606/G07001012516060/ 102717, 117901, 127002;\n010-125-1808/G07001012518080/ 103005, 117902, 127704;\n010-207-1007/G07001020710070/ 102702, 106201, 118003, 125102;\n010-207-1007-2/G070010207100720/ 117511, 124106, 127717, 114303;\n010-207-1209/G07001020712090/ 102701, 105401, 124101, 127705, 101201;\n010-207-1411/G07001020714110/ 105001, 105402, 101203;\n010-207-1613/G07001020716130/ 103007, 105403, 124102, 127706;\n010-213-1206/G07001021312060/ 105002, 105404, 121202, 124103, 127707, 101204;\n010-213-1408/G07001021314080/ 102704, 105405, 121203, 124104, 127708;\n010-213-1610/G07001021316100/ 103008, 105406, 130101;\n010-213-1812/G07001021318120/ 103009, 105407, 127709;\n010-219-1406/G07001021914060/ 102705, 105408, 117503, 119301, 121201, 124105;\n010-219-1608/G07001021916080/ 103010, 105409, 121204, 127710;\n010-219-1810/G07001021918100/ 103011, 105410, 127711;\n010-225-1807/G07001022518070/ 102706, 113701, 117001, 121205;\n010-225-2009/G07001022520090/ 103001, 117903, 127004, 127712;\n010-307-1006/G07001030710060/ 102707, 106202, 118004, 129302;\n010-307-1006-2/G070010307100620/ 117512, 127718, 114304;\n010-307-1208/G07001030712080/ 102709, 105601, 117504;\n010-307-1410/G07001030714100/ 102710, 105602, 127713;\n010-307-1612/G07001030716120/ 103012, 105603, 117505;\n010-313-1205/G07001031312050/ 103013, 105604, 117506, 129303;\n010-313-1407/G07001031314070/ 102711, 105605, 117507, 124107, 128702, 130102;\n010-313-1609/G07001031316090/ 103014, 105606;\n010-313-1811/G07001031318110/ 103015, 105607, 127714;\n010-313-2013/G07001031320130/ 103016, 105608, 127715;\n010-319-1606/G07001031916060/ 102712, 105609, 114905, 117508;\n010-319-1808/G07001031918080/ 103017, 105610, 125103;\n010-319-2010/G07001031920100/ 103018, 105611, 125104;\n010-325-2007/G07001032520070/ 102713, 105612, 121206;\n010-325-2209/G07001032522090/ 105613, 121207, 101206, 101207, 101208", "firm_fei_number": "3020307303", "recalling_firm": "Novapproach Spine, LLC", "address_1": "13900 Tech City Cir Ste 300 13900 Tech City Cir", "address_2": "Ste 300", "city": "Alachua", "state": "FL", "postal_code": "32615-6091", "additional_info_contact": "386-588-3408", "reason_for_recall": "Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.", "root_cause_description": "Process design", "action": "On 4/23/2026, removal notices were sent to customers who were asked to do the following:\n1) Return affected devices using the return label.\n2) Firm is providing unaffected kits.\n\nIf you have recall-related questions contact firm at Ron.Green@NovApproachspine.com", "product_quantity": "1259", "distribution_pattern": "US Nationwide distribution in the states of NY, CT, CA, TX, FL, MI.", "openfda": { "k_number": [ "K202190", "K192047", "K191263", "K240623", "K222009", "K102738", "K240368", "K261353", "K192492", "K160291", "K221751", "K181818", "K201671", "K071922", "K102121", "K121211", "K081395", "K243191", "K251829", "K241992", "K123767", "K123045", "K250845", "K131276", "K073109", "K142095", "K131723", "K100802", "K133286", "K160597", "K141942", "K203207", "K081849", "K191091", "K100516", "K200338", "K192054", "K120557", "K211837", "K180002", "K141187", "K102090", "K142271", "K161223", "K221545", "K130445", "K213935", "K092211", "K121982", "K240126", "K180215", "K201087", "K232123", "K161993", "K142487", "K250603", "K211769", "K162236", "K200002", "K243386", "K083475", "K151214", "K191581", "K162351", "K243635", "K130461", "K161173", "K160051", "K192993", "K251459", "K172941", "K133328", "K233966", "K201585", "K212967", "K132596", "K161129", "K133947", "K231486", "K261809", "K230731", "K082252", "K253401", "K181118", "K120869", "K142645", "K170855", "K212980", "K250072", "K081711", "K254202", "K124034", "K202032", "K180695", "K232154", "K120101", "K221324", "K151312", "K122168", "K221936", "K102402", "K161379", "K230808", "K230894", "K222561", "K080822", "K232097", "K241077", "K220115", "K112700", "K160605", "K150643", "K180519", "K183426", "K093808", "K251644", "K103369", "K181386", "K193593", "K182195", "K241321", "K214047", "K173606", "K153720", "K192168", "K223413", "K091301", "K143228", "K241477", "K140479", "K223146", "K260810", "K243802", "K141791", "K163269", "K173082", "K202230", "K131547", "K110327", "K082926", "K101310", "K251575", "K141798", "K232530", "K091813", "K190179", "K232432", "K170157", "K180814", "K172328", "K081501", "K140106", "K170592", "K113285", "K190877", "K221447", "K142066", "K261408", "K111626", "K150673", "K172019", "K241487", "K173432", "K253559", "K170455", "K112561", "K212498", "K130641", "K072253", "K120031", "K131122", "K162680", "K133827", "K100043", "K180502", "K191834", "K210271", "K171567", "K222554", "K213118", "K163670", "K143163", "K243934", "K133494", "K163543", "K200541", "K151481", "K193320", "K203742", "K152943", "K103382", "K142498", "K200352", "K132559", "K111122", "K182139", "K123993", "K172083", "K181096", "K210590", "K093629", "K220610", "K182007", "K110063" ], "registration_number": [ "1000517406", "1000200989", "3037407500", "3009241418", "3012966183", "3018210489", "3008864603", "1724955", "3008850074", "3010041430", "3010560653", "3015212339", "3005739886", "3006846753", "3015216945", "1057425", "3015398319", "3010047454", "3017980495", "3003597504", "3005031160", "3014725904", "3010120104", "1030489", "2531195", "3012028003", "3010531069", "3036756245", "3004142400", "2648623", "2134470", "3014680795", "9616680", "3013422236", "8020776", "3013820501", "3004112448", "3010363503", "3010160527", "1835251", "3004774118", "1834331", "1834379", "3043543260", "9611813", "3009051471", "1220477", "2028632", "3005641619", "1225492", "3000270450", "3017048829", "3024999441", "3009144915", "3011795235", "3004024955", "3009049161", "2183946", "1319660", "3010386387", "3005677016", "3003637761", "1835444", "3007728266", "3009189869", "3010863450", "2032098", "3004717358", "3006017180", "3005706667", "3008262872", "3009887475", "3010057495", "2134285", "3004188066", "3009888740", "1924669", "3014273501", "3009882462", "3012131184", "3015876273", "3013194153", "3009959868", "2032093", "3009973336", "3012428435", "3019878714", "3013413393", "1000432246", "3013491327", "1424434", "3015399803", "3019837678", "3010120326", "2183744", "3013422238", "3004893332", "3003387384", "3009998573", "1720929", "3003477135", "3012764194", "3015882686", "3003935342", "3009417901", "3010326971", "3010120148", "3016443334", "3010178296", "3009756327", "3006791286", "3010370500", "3026776", "2027062", "3005596514", "2647346", "1833920", "3010866843", "3017565094", "1824199", "3003761012", "1424263", "3008110533", "3007922509", "3014967969", "1047843", "3007289746", "1450662", "3003435550", "2031966", "3005497913", "3033509898", "9617544", "3005061536", "3009149199", "1527105", "1833824", "3000170817", "1221763", "9611390", "2531477", "3025603301", "3016237080", "1526534", "3009973699", "1420032", "3004788213", "3005819474", "2135156", "3017936978", "3014252644", "3008114965", "3008583793", "3003898943", "3010705004", "3010047402", "3006404071", "1423662", "3010462278", "3012711663", "3002807561", "3005144609", "1526711", "3010120135", "3010370554", "1833986", "3010041499", "3016084569", "1529009", "3020307303", "3017597868", "9615766", "3006272282", "3010162973", "3004153896", "3010663372", "3011390763", "3006783837", "3013055499", "3015179588", "3031081659", "3008812560", "1928237", "3015869493", "9610612", "3007303113", "3008868758", "3008992889", "3022295665", "3006694268", "1835296", "3016050940", "2532027", "3009380063", "2027467", "3015151147", "3014655115", "3010097171", "1530390", "3015941638", "3003639920", "3006563559", "3010531060", "3013758617", "3004635447", "3006639944", "3007766698", "3011577940", "3010032903", "3016112537", "9681465", "2032521", "1649379", "3013462427", "3019767615", "3018094310", "3012120772", "3016460869", "3039167712", "3009973505", "3011127597", "3010123206", "1935627", "3007993775", "3016668776", "3012447612", "8043792", "2183449", "1649518", "2133928", "3006128100", "3004638600", "2029275", "3017528621", "3003525643", "3006982954", "2530808", "1828464", "3010197239", "3023852420", "3004499989", "1226544", "3009504230", "3030412764", "3004719693", "3009882675", "3011187779", "3008773560", "1526439", "3005178931", "3009962553", "3003120897", "3010009693", "3010197224", "3005180920", "3015869492", "3010049501", "3016438694" ], "fei_number": [ "1000517406", "3002806685", "1000200989", "3037407500", "3009241418", "3012966183", "4224", "3018210489", "1000136478", "3008864603", "3000210784", "3008850074", "1000115656", "1000115331", "3010041430", "3010560653", "3015212339", "3005739886", "3006846753", "3015216945", "3010047454", "3017980495", "3003597504", "3005031160", "3014725904", "3010120104", "1000522098", "3012028003", "3010531069", "1000221916", "3036756245", "2648623", "3003058119", "3014680795", "3004112448", "3013422236", "3004142400", "3013820501", "3010363503", "1000306340", "3002807038", "3043543260", "3002459190", "3009051471", "1220477", "3003574398", "3005641619", "1000139987", "3000270450", "3017048829", "3024999441", "3009144915", "3011795235", "3004024955", "3009049161", "3010386387", "3005677016", "3003637761", "1000306431", "3007728266", "3009189869", "3010863450", "3004717358", "3006017180", "3005706667", "3008262872", "3009887475", "3010057495", "3004188066", "3009888740", "1924669", "3014273501", "3009882462", "3012131184", "3015876273", "3013194153", "3009959868", "3009973336", "3012428435", "3003015552", "3019878714", "3013413393", "3003142829", "1000432246", "3013491327", "3015399803", "3019837678", "3010120326", "2183744", "3013422238", "3002795782", "3004893332", "3003387384", "3009998573", "3000717687", "1720929", "3003477135", "3012764194", "1000125025", "3015882686", "3003935342", "3009417901", "3010326971", "3010120148", "3016443334", "3002807113", "3010370500", "3006791286", "1000477302", "3008647423", "2027062", "3005596514", "2647346", "3010866843", "3017565094", "1824199", "3003761012", "3008110533", "3007922509", "1000306303", "3014967969", "3007289746", "1047843", "1450662", "3003435550", "3005497913", "3033509898", "3005061536", "3009322142", "3009149199", "3000170817", "1221763", "3025603301", "3016237080", "3003112432", "1000116116", "1526534", "3009973699", "1420032", "3004788213", "3005819474", "3017936978", "3014252644", "3008114965", "3008583793", "3003898943", "3010705004", "3010047402", "3006404071", "3010462278", "3012711663", "3002807561", "3005144609", "1526711", "3010120135", "3002462840", "3003690049", "3010370554", "3016084569", "3020307303", "3017597868", "3006272282", "3004153896", "3003128516", "3010663372", "3001236277", "3011390763", "3013055499", "3015179588", "3031081659", "3008812560", "1928237", "3015869493", "3007303113", "3008868758", "3000717902", "3008992889", "3002980729", "3022295665", "1000069183", "3006694268", "3016050940", "3009380063", "2027467", "3015151147", "3014655115", "3010097171", "3001642380", "3003639920", "3006563559", "3010531060", "3013758617", "3004635447", "3006639944", "3007766698", "3011577940", "3000215103", "3001237338", "3010032903", "3016112537", "1000135253", "3003292403", "3002807041", "3013462427", "3019767615", "3018094310", "3012120772", "3016460869", "3039167712", "3000215273", "3009973505", "3010123206", "3011127597", "3007932279", "1935627", "3007993775", "3016668776", "3003058448", "3012447612", "3008599177", "2183449", "3006128100", "3004638600", "3017528621", "3009256700", "3003179719", "3003525643", "3002808269", "3011764740", "3002806315", "3006982954", "1828464", "3010197239", "3023852420", "3004499989", "3009504230", "3030412764", "3004719693", "3002287318", "3011187779", "3008773560", "3003110073", "3002806773", "1526439", "3005178931", "3009962553", "3003120897", "3010009693", "3000718490", "3010197224", "3002807040", "3000205591", "3015869492", "1000149660", "3005180920", "3010049501", "3000207350", "3016438694" ], "device_name": "Intervertebral Fusion Device With Integrated Fixation, Lumbar", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3080", "device_class": "2" } } ] }