{ "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": "196860", "product_res_number": "Z-0559-2023", "event_date_initiated": "2022-11-01", "event_date_posted": "2022-12-14", "recall_status": "Open, Classified", "res_event_number": "91125", "product_code": "PGN", "k_numbers": [ "K201543" ], "product_description": "NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. \n\nREF Model Numbers/NSO Item #/Product Description\nMC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard\nMC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard\nMC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset\nMC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset\nMC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset\nMC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard\nMC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard\nMC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard\nMC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard\nMC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset\nMC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset\nMC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset\nMC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard\nMC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset\nMC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard\nMC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset", "code_info": "REF Model Numbers/NSO Item #/Product Description/UDI-DI Code:\nMC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard / 812258022624\nLot Numbers:\n0013101BAB\n2091504AAA\n8091013BAB\n8121214BAD\n9031814BAB\n9061902BAB\n2082304AAA\n8060409BAB\n8092007BAB\n8121312BAB\n9032005BAB\n9061911BAB\n2082306AAA\n8060601BAB\n8092102BAB\n8121406BAB\n9032006BAB\n9061912BAB\n2082309AAA\n8061921BAB\n8092404BAB\n8121406BAC\n9032006BAC\n9061912BAC\n2082412AAA\n8070615BAB\n8100410BAB\n9010806BAB\n9032007BAB\n9062018BAB\n2091201AAA\n8070902BAB\n8100410BAC\n9011803BAB\n9032007BAC\n9062411BAB\n2091202AAA\n8071213BAB\n8111306BAB\n9011803BAC\n9032014BAB\n9062412BAB\n2091211AAA\n8071706BAB\n8111415BAB\n9020405BAB\n9032101BAB\n9062412BAC\n2091212AAA\n8072105BAB\n8121109BAB\n9021216BAB\n9032102BAB\n9062413BAB\n2091303AAA\n8082313BAB\n8121109BAC\n9021302BAB\n9051011BAC\n9062508BAB\n2091304AAA\n8082401BAB\n8121111BAB\n9021306BAB\n9051016BAB\n9062517BAB\n2091312AAA\n8082410BAB\n8121205BAB\n9022204BAB\n9051016BAC\n9062519BAB\n2091314AAA\n8082701BAB\n8121211BAB\n9022204BAC\n9061812BAB\n9062520BAB\n2091403AAA\n8082814BAB\n8121214BAB\n9022204BAD\n9061819BAB\n9062702BAB\n2091405AAA\n8090709BAB\n8121214BAC\n9031107BAB\n9061901BAB\n9072313BAB\n9072314BAB\n9081307BAB\n9090931BAC\n9091002BAB\n9121635BAB\n9121719BAB\n9072516BAB\n9081312BAB\n9090956BAB\n9093010BAB\n9121711BAB\n9072601BAB\n9090930BAB\n9090956BAC\n9111222BAB\n9121712BAB\n9080301BAB\n9090931BAB\n9091001BAB\n9112013BAB\n9121713BAB\n\nMC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard / 812258022662\nLot Numbers:\n0010620BAB\n8070512BAB\n9071302BAB\n9090410BAC\n8121801BAC\n9032222BAB\n0010620BAC\n8080401BAB\n9071302BAC\n9091714BAB\n8121802BAB\n9041701BAB\n0010621BAB\n8080612BAB\n9071517BAB\n9091714BAC\n9012309BAB\n9041706BAB\n0013113BAB\n8080812BAB\n9072315BAB\n9091801BAB\n9012309BAC\n9041707BAB\n0013113BAC\n8081703BAB\n9072318BAB\n9111301BAB\n9012332BAB\n9050704BAB\n0013113BAD\n8091103BAB\n9072319BAB\n9111302BAB\n9012404BAB\n9050706BAB\n1041203AAA\n8092107BAB\n9072415BAB\n9111302BAC\n9012404BAC\n9050712BAB\n1041204AAA\n8092405BAB\n9072415BAC\n9111306BAB\n9012410BAB\n9050806BAB\n1050405AAA\n8092411BAB\n9072420BAB\n9112119BAB\n9030612BAB\n9051004BAB\n1100709AAA\n8100101BAB\n9072420BAC\n9112119BAC\n9030703BAB\n9070915BAB\n2070513AAA\n8100414BAB\n9072421BAB\n9112201BAB\n9030823BAB\n9070916BAB\n2070515AAA\n8101813BAB\n9072421BAC\n9112201BAC\n9030826BAB\n9071111BAB\n2070611AAA\n8110105BAB\n9080812BAB\n9112209BAB\n9030901BAB\n9071208BAB\n2082413AAA\n8111257BAB\n9080812BAC\n9112209BAC\n9030902BAB\n9071209BAB\n2082415AAA\n8111257BAC\n9080812BAD\n9112209BAD\n9030904BAB\n9071209BAC\n2082501AAA\n8112604BAB\n9080812BAE\n9112210BAB\n9031102BAB\n9120306BAB\n2082603AAA\n8112604BAC\n9080813BAB\n9112211BAB\n9032119BAB\n9120307BAB\n2082604AAA\n8112610BAB\n9081301BAB\n9112523BAB\n9032119BAC\n9120401BAB\n2092301AAA\n8112610BAC\n9081917BAB\n8120625BAB\n9032120BAB\n9120401BAC\n8050703BAB\n8120619BAB\n9081917BAC\n8120722BAB\n9032205BAB\n9120401BAD\n8062113BAB\n8120619BAC\n9082601BAB\n8121704BAB\n9032212BAB\n9121809BAB\n8062511BAB\n9071209BAD\n9082601BAC\n8121705BAB\n9032213BAB\n9121810BAB\n8062702BAB\n9071301BAB\n9082602BAB\n8121717BAB\n9032217BAB\n9121815BAB\n8062808BAB\n9071301BAC\n9090410BAB\n8121801BAB\n9032217BAC\n9121815BAC\n\nMC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset / 812258022709\nLot Numbers:\n1093019AAA\n1102826AAA\n2092814AAA\n8051503BAB\n8091011BAB\n9031821BAB\n1100710AAA\n1110503AAA\n2092815AAA\n8051601BAB\n8092703BAB\n9061510BAB\n1100710AAB\n1110504AAA\n2100407AAA\n8071214BAB\n8100533BAB\n9082004BAB\n1100817AAA\n1110802AAA\n2100605AAA\n8071219BAB\n8121902BAB\n9092001BAB\n1102715AAA\n1111605AAA\n2101113AAA\n8080103BAB\n9012209BAB\n9120901BAB\n1102801AAA\n1113011AAA\n8043010BAB\n8080103BAC\n9012209BAC\n9121309BAB\n1102818AAA\n1120210AAA\n8051205BAB\n8081508BAB\n9012424BAB\n1102824AAA\n1120336AAA\n8051409BAB\n8090508BAB\n9012424BAC\n\nMC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset / 812258022631\nLot Numbers:\n0010301BAB\n8071116BAB\n8091005BAB\n9010909BAC\n9062803BAB\n9081901BAB\n0010333BAB\n8072518BAB\n8091005BAC\n9010909BAD\n9062819BAB\n9081902BAB\n0010818BAB\n8072518BAC\n8091118BAB\n9012422BAB\n9071201BAB\n9081911BAB\n1040502AAA\n8072520BAB\n8091118BAC\n9022811BAB\n9071717BAB\n9092011BAB\n1040804AAA\n8072520BAC\n8091122BAB\n9032503BAB\n9072003BAB\n9121310BAB\n1040805AAA\n8073004BAB\n8092414BAB\n9051306BAB\n9072004BAB\n9121311BAB\n8062009BAB\n8080706BAB\n8092414BAC\n9051407BAB\n9072706BAB\n9121311BAC\n8062101BAB\n8081313BAB\n8092508BAB\n9051411BAB\n9072706BAC\n9121312BAB\n8062107BAB\n8081313BAC\n8092508BAC\n9051419BAB\n9073023BAB\n8062125BAB\n8082802BAB\n8092508BAD\n9061712BAB\n9073023BAC\n8070701BAB\n8082903BAB\n8100505BAB\n9061722BAB\n9080814BAB\n8070702BAB\n8090705BAB\n8111411BAB\n9062801BAB\n9080814BAC\n8071113BAB\n8090705BAC\n8121813BAB\n9062802BAB\n9080815BAB\n\nMC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset / 812258022679\nLot Numbers:\n0010335BAB\n2092204AAA\n8080809BAB\n9122001BAB\n9032601BAC\n9062107BAB\n0010335BAC\n2092206AAA\n8081103BAB\n8092415BAB\n9032603BAB\n9062403BAB\n0010336BAB\n8060107BAB\n8081104BAB\n8092415BAC\n9032628BAB\n9062403BAC\n0012801BAB\n8060517BAB\n8082215BAB\n8092502BAB\n9032633BAB\n9062622BAB\n0012801BAC\n8060605BAB\n8082215BAC\n8092505BAB\n9051431BAB\n9062622BAC\n0012802BAB\n8062019BAB\n8090504BAB\n8100509BAB\n9051501BAB\n9062622BAD\n0012802BAC\n8062112BAB\n8090724BAB\n9010919BAB\n9051504BAB\n9062623BAB\n0012829BAB\n8070505BAB\n8091101BAB\n9012002BAB\n9051506BAB\n9073007BAB\n0012901BAB\n8071327BAB\n8091211BAB\n9012002BAC\n9051506BAC\n9081401BAB\n1040602AAA\n8071608BAB\n8091221BAB\n9012125BAB\n9051601BAB\n9081402BAB\n1041201AAA\n8071711BAB\n8091221BAC\n9012425BAB\n9051602BAB\n9081412BAB\n1041202AAA\n8071814BAB\n8091702BAB\n9022110BAB\n9051603BAB\n9081417BAB\n1050404AAA\n8071910BAB\n8091702BAC\n9022801BAB\n9060408BAB\n9081417BAC\n1050407AAA\n8072305BAB\n9112019BAB\n9022801BAC\n9060408BAC\n9081601BAB\n2070519AAA\n8073006BAB\n9112020BAB\n9032511BAB\n9060411BAB\n2070606AAA\n8080217BAB\n9112020BAC\n9032601BAB\n9062106BAB\n\nMC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard / 812258022716\nLot Numbers:\n1041303ZZZ\n1110111AAA\n2011419ZZZ\n8041635BAB\n8121810BAB\n9112301BAC\n1041304ZZZ\n1110206AAA\n2011702ZZZ\n8042402BAB\n9021209BAB\n9120402BAB\n1070605ZZZ\n1110207AAA\n2062812ZZZ\n8071005BAB\n9022526BAB\n9120416BAB\n1070606ZZZ\n1110208AAA\n2062813ZZZ\n8072011BAB\n9022536BAB\n9120417BAB\n1082317ZZZ\n1110901AAA\n2082410ZZZ\n8072103BAB\n9051103BAB\n9120501BAB\n1082318ZZZ\n1112310AAA\n2082411ZZZ\n8080113BAB\n9051104BAB\n9120502BAB\n1092843AAA\n1112315AAA\n2090607ZZZ\n8080605BAB\n9071718BAB\n9121009BAB\n1092928AAA\n1112907AAA\n2093015AAA\n8081605BAB\n9072424BAB\n9121016BAB\n1100711AAA\n1120615AAA\n2093018AAA\n8091704BAB\n9100203BAB\n9121441BAB\n1100818AAA\n1120803AAA\n2100401AAA\n8091705BAB\n9100204BAB\n9121441BAC\n1102709ZZZ\n1120910AAA\n2100701AAA\n8120705BAB\n9100207BAB\n1102710ZZZ\n1120914AAA\n2101114AAA\n8121805BAB\n9112301BAB\n\nMC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard / 812258022600\nLot Numbers:\n1040802AAA\n2071816AAA\n8061318BAB\n8092738BAB\n9011712BAB\n9040110BAC\n1040803AAA\n2071901AAA\n8062307BAB\n8110505BAB\n9021401BAB\n9040110BAD\n2051606AAA\n2082605AAA\n8062622BAB\n8111322BAB\n9021402BAB\n9051701BAB\n2051945AAA\n2082901AAA\n8063005BAB\n8111414BAB\n9021404BAB\n9051801BAB\n2051946AAA\n2082902AAA\n8063005BAC\n8112108BAB\n9021404BAC\n9051802BAB\n2051947AAA\n2082906AAA\n8070206BAB\n8120727BAB\n9030102BAB\n9052008BAB\n2052001AAA\n2090808AAA\n8071001BAB\n8120902BAB\n9030104BAB\n9052010BAB\n2052303AAA\n2090810AAA\n8072508BAB\n8120902BAC\n9031501BAB\n9061124BAB\n2052513AAA\n2090815AAA\n8072510BAB\n8121328BAB\n9031501BAC\n9061125BAB\n2052514AAA\n2090902AAA\n8080902BAB\n8121904BAB\n9032708BAB\n9061126BAB\n2070801AAA\n2090903AAA\n8081001BAB\n8121904BAC\n9032711BAB\n9061220BAB\n2070803AAA\n2090906AAA\n8091324BAB\n9011601BAB\n9032714BAB\n9061221BAB\n2071102AAA\n2090917AAA\n8091404BAB\n9011611BAB\n9032801BAB\n9061221BAC\n2071808AAA\n8061203BAB\n8091404BAC\n9011611BAC\n9032807BAB\n9061221BAD\n2071811AAA\n8061218BAB\n8091701BAB\n9011627BAB\n9040110BAB\n9071726BAB\n9071727BAB\n9082101BAB\n9091601BAB\n9091701BAB\n9092417BAB\n9112016BAB\n9071732BAB\n9082101BAC\n9091619BAB\n9091702BAB\n9093011BAB\n9112017BAB\n9071826BAB\n9082102BAB\n9091620BAB\n9091712BAB\n9100701BAB\n9122059BAB\n9071905BAB\n9090438BAB\n9091620BAC\n9092414BAB\n9112014BAB\n9122063BAB\n9071906BAB\n9090438BAC\n9091620BAD\n9092415BAB\n9112015BAB\n9122101BAB\n\nMC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard / 812258022648\nLot Numbers:\n0012222BAB\n1050406AAA\n8070502BAB\n9091116BAB\n8102323BAC\n9032814BAB\n0012222BAC\n2070616AAA\n8082017BAB\n9121401BAB\n8102411BAB\n9052120BAB\n0012301BAB\n8060103BAB\n8082017BAC\n9121437BAB\n8111603BAB\n9052121BAB\n0012302BAB\n8060503BAB\n8082022BAB\n9122102BAB\n8121051BAB\n9052122BAB\n0012304BAB\n8060611BAB\n8082022BAC\n9122603BAB\n8121051BAC\n9052209BAB\n0012317BAB\n8060613BAB\n8082105BAB\n8082204BAB\n8121056BAB\n9052210BAB\n0012318BAB\n8060702BAB\n8082105BAC\n8082213BAB\n8121060BAK\n9060413BAB\n0012401BAB\n8060702BAC\n8082201BAB\n8082213BAC\n8121330BAB\n9060413BAC\n0012415BAB\n8062017BAB\n8082201BAC\n8083008BAB\n9011903BAB\n9060516BAB\n0012419BAB\n8062121BAB\n9062003BAB\n8090401BAB\n9021405BAB\n9060516BAC\n0012713BAB\n8062124BAB\n9062004BAB\n8092608BAB\n9021502BAB\n9061224BAB\n0012714BAB\n8062322BAB\n9062005BAB\n8100809BAB\n9021520BAB\n9061224BAC\n0013115BAB\n8062628BAB\n9082001BAB\n8100809BAC\n9022605BAB\n9061225BAB\n0013116BAB\n8062628BAC\n9082002BAB\n8101904BAB\n9031410BAB\n9061314BAB\n1040702AAA\n8062718BAB\n9082933BAB\n8102306BAB\n9031901BAB\n1040905AAA\n8062905BAB\n9083001BAB\n8102306BAC\n9032810BAB\n1040906AAA\n8062905BAC\n9091019BAB\n8102320BAB\n9032810BAC\n1050403AAA\n8063010BAB\n9091021BAB\n8102323BAB\n9032812BAB\n\nMC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard / 812258022686\nLot Numbers:\n1101912AAA\n1102927AAA\n8041808BAB\n8080402BAB\n8092014BAC\n9120521BAB\n1102001AAA\n1102928AAA\n8050203BAB\n8083007BAB\n8092014BAD\n9120526BAB\n1102004AAA\n1110105AAA\n8050303BAB\n8083007BAC\n9042611BAB\n9120528BAB\n1102013AAA\n1110108AAA\n8050401BAB\n8092001BAB\n9061503BAB\n9121203BAB\n1102015AAA\n1110110AAA\n8051711BAB\n8092001BAC\n9073115BAB\n9122334BAB\n1102015AAB\n1110210AAA\n8051711BAC\n8092001BAD\n9091803BAB\n9122602BAB\n1102204AAA\n1112317AAA\n8051715BAB\n8092012BAB\n9102401BAB\n1102204AAB\n1113022AAA\n8062828BAB\n8092012BAC\n9120510BAB\n1102926AAA\n1120705AAA\n8080101BAB\n8092014BAB\n9120517BAB\n\nMC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset / 812258022617\nLot Numbers:\n1040505AAA\n9011428BAC\n9032901BAB\n9071521BAB\n9073022BAB\n9091906BAB\n1040801AAA\n9011429BAB\n9032914BAB\n9071610BAB\n9073022BAC\n9112302BAB\n2092105AAA\n9011429BAC\n9032914BAC\n9071610BAC\n9073022BAD\n9121924BAB\n2092106AAA\n9021601BAB\n9032915BAB\n9071617BAB\n9081501BAB\n9121924BAC\n8111504BAB\n9021603BAB\n9032915BAC\n9072215BAB\n9081501BAC\n9121938BAB\n8111508BAB\n9022703BAB\n9042508BAB\n9072701BAB\n9081502BAB\n9121938BAC\n8122101BAB\n9031511BAB\n9042601BAB\n9072702BAB\n9081502BAC\n9121941BAB\n9011102BAB\n9031601BAB\n9070104BAB\n9072705BAB\n9082113BAB\n9121941BAC\n9011102BAC\n9032002BAB\n9070112BAB\n9073001BAB\n9082113BAC\n9122622BAB\n9011428BAB\n9032002BAC\n9071114BAB\n9073001BAC\n9091905BAB\n9122622BAC\n\nMC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset / 812258022655\nLot Numbers:\n1040601AAA\n8081511BAC\n8102503BAC\n9022814BAB\n9060309BAB\n9090444BAB\n1040701AAA\n8081602BAB\n8111908BAB\n9030707BAB\n9060317BAB\n9090444BAC\n1040903AAA\n8081602BAC\n8111908BAC\n9030810BAB\n9060703BAB\n9091804BAB\n1040904AAA\n8081713BAB\n8112015BAB\n9040114BAB\n9060707BAB\n9091805BAB\n1050401AAA\n8092602BAB\n8112015BAC\n9040201BAB\n9060714BAB\n9091805BAD\n1050402AAA\n8092602BAC\n8112015BAD\n9052304BAB\n9060714BAC\n9121316BAB\n1100708AAA\n8100811BAB\n8112112BAB\n9052304BAC\n9060804BAB\n9121316BAC\n1100812AAA\n8100811BAC\n8112112BAC\n9052316BAB\n9060804BAC\n9121317BAB\n2070619AAA\n8100811BAD\n8122110BAB\n9052321BAB\n9061006BAB\n8072701BAB\n8102201BAB\n8122607BAB\n9052321BAC\n9061018BAB\n8081408BAB\n8102212BAB\n9021606BAB\n9052406BAB\n9061032BAB\n8081416BAB\n8102212BAC\n9021607BAB\n9052406BAC\n9061105BAB\n8081511BAB\n8102503BAB\n9022102BAB\n9060306BAB\n9061105BAC\n\nMC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset / 812258022693\nLot Numbers:\n1101510AAA\n1102014AAA\n1102506AAA\n1112901AAA\n9120518BAB\n9122620BAB\n1101801AAA\n1102101AAA\n1102510AAA\n1113008AAA\n9120531BAB\n9122620BAC\n1101802AAA\n1102103AAA\n1102511AAA\n1113050AAA\n9120632BAB\n9122621BAB\n1101803AAA\n1102106AAA\n1102716AAA\n1120161AAA\n9120633BAB\n9122621BAC\n1101909AAA\n1102206AAA\n1102925AAA\n9120511BAB\n9121202BAB\n\nMC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard / 81225809265\nLot Numbers:\n1092841AAA\n2051323AAA\n9012301BAC\n2081708AAA\n7092301BAB\n9101610BAB\n1092842AAA\n2051325AAA\n9012301BAD\n2081801AAA\n7110102BAB\n9110107BAB\n1092851AAA\n2051617AAA\n9021802BAB\n2081804AAA\n8040917BAB\n9110107BAC\n1092852AAA\n2051701AAA\n9021807BAB\n2081812AAA\n8043003BAB\n9110107BAD\n1092926AAA\n2052308AAA\n9021903BAB\n2081814AAA\n8050908BAB\n9110108BAB\n1092927AAA\n2052408AAA\n9021906BAB\n2081902AAA\n8050908BAC\n9110108BAC\n1093017AAA\n2052409AAA\n9021908BAB\n2081907AAA\n8051511BAB\n9110110BAB\n1093018AAA\n2052410AAA\n9021908BAC\n2081909AAA\n8082002BAB\n9110401BAB\n1100702AAA\n2052512AAA\n9030521BAB\n2082219AAA\n8082002BAC\n9110401BAC\n1101110AAA\n2081533AAA\n9030610BAB\n2082222AAA\n8082805BAB\n9110401BAD\n1101307AAA\n2081537AAA\n9040102BAB\n2082302AAA\n8082805BAC\n9110407BAB\n1101309AAA\n2081630AAA\n9041005BAB\n2083004AAA\n8083006BAB\n9110408BAB\n1101313AAA\n2081635AAA\n9041005BAC\n2083005AAA\n8083006BAC\n9110408BAC\n1101409AAA\n2081701AAA\n9041008BAB\n2083007AAA\n8091806BAB\n9110901BAB\n1101410AAA\n2081703AAA\n9042412BAB\n2083008AAA\n8110104BAB\n9110902BAB\n1101413AAA\n8110515BAB\n9042414BAB\n2083101AAA\n9061106BAB\n9110903BAB\n1110306AAA\n8110515BAC\n9042501BAB\n2090101AAA\n9061120BAB\n9110904BAB\n1110307AAA\n8111901BAB\n9050819BAB\n2090120AAA\n9061120BAC\n9111109BAB\n1110308AAA\n8120903BAB\n9052408BAB\n2090122AAA\n9061310BAB\n9111110BAB\n1110405AAA\n8120904BAB\n9052409BAB\n2090123AAA\n9082202BAB\n9112021BAB\n1110406AAA\n8120905BAB\n9052804BAB\n2092701AAA\n9082202BAD\n9112022BAB\n1110410AAA\n8121923BAB\n9052805BAB\n2092710AAA\n9082801BAB\n9112023BAB\n1110501AAA\n8122007BAB\n9052805BAC\n2100406AAA\n9082802BAB\n9112023BAC\n1112408AAA\n8122011BAB\n9052816BAB\n2100601AAA\n9101401BAB\n9112101BAB\n1112910AAA\n8122011BAC\n9052816BAC\n2101101AAA\n9101403BAB\n9112102BAB\n1120164AAA\n9010801BAB\n9052817BAB\n2101301AAA\n9101403BAC\n9112611BAB\n1120708AAA\n9011114BAB\n9052817BAC\n7083105BAB\n9101415BAB\n2051203AAA\n9011816BAB\n9053025BAB\n7090806BAB\n9101416BAB\n2051204AAA\n9011816BAC\n9053112BAB\n7091505BAB\n9101601BAB\n2051205AAA\n9012301BAB\n9060105BAB\n7092214BAB\n9101601BAC\n\nMC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset / 81225809272\nLot Numbers:\n0010403BAB\n0011601BAB\n7112002BAB\n8103050BAC\n9042308BAC\n9082306BAC\n0010404BAB\n0011602BAB\n7112213BAB\n8112008BAB\n9042309BAB\n9082706BAB\n0010404BAC\n1111601AAA\n8020716BAC\n8122606BAB\n9042309BAC\n9091201BAB\n0011317BAB\n1121305AAA\n8030601BAE\n9011103BAB\n9050902BAB\n9091202BAB\n0011317BAC\n2092203AAA\n8042507BAB\n9011103BAC\n9060107BAB\n9091202BAC\n0011318BAB\n2092612AAA\n8042804BAB\n9022001BAB\n9060107BAC\n9091317BAB\n0011319BAB\n2100304AAA\n8062818BAB\n9022114BAB\n9060604BAB\n9091317BAC\n0011319BAC\n2100503AAA\n8091403BAB\n9022114BAC\n9060604BAC\n9091318BAB\n0011401BAB\n2101007AAA\n8091403BAC\n9031406BAB\n9060611BAB\n9100333BAB\n0011402BAB\n2101201AAA\n8100818BAB\n9031406BAC\n9060614BAB\n9100333BAC\n0011402BAC\n7083108BAB\n8101159BAB\n9031406BAD\n9061412BAB\n9100334BAB\n0011506BAB\n7091602BAB\n8102314BAB\n9031414BAB\n9082216BAB\n9100407BAB\n0011524BAB\n7092302BAB\n8102314BAC\n9042301BAB\n9082216BAC\n9100408BAB\n0011525BAB\n7100401BAB\n8103027BAB\n9042305BAB\n9082305BAB\n9121402BAB\n0011525BAC\n7102501BAB\n8103050BAB\n9042308BAB\n9082306BAB\n9121402BAC\n\nMC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard / 81225809296\nLot Numbers:\n0010742BAB\n1101111AAA\n7092303BAB\n8080403BAB\n9030415BAB\n9082614BAB\n0010743BAB\n1101205AAA\n7092605BAB\n8091906BAB\n9030504BAB\n9082701BAB\n0010770BAB\n1101206AAA\n7092605BAC\n8091909BAB\n9030504BAC\n9082701BAC\n0010771BAB\n1101303AAA\n7092802BAC\n8091909BAC\n9042001BAB\n9082702BAB\n0010773BAB\n1101904AAA\n7112003BAC\n8100919BAB\n9042002BAB\n9082704BAB\n0011643BAB\n1101905AAA\n7112803BAC\n8102313BAB\n9042004BAB\n9090511BAB\n0011644BAB\n2091604AAA\n7121410BAB\n8102501BAB\n9042209BAB\n9090511BAC\n0011714BAB\n2091905AAA\n8041114BAB\n8103117BAB\n9042214BAB\n9090512BAB\n0011715BAB\n2092201AAA\n8042408BAB\n8103150BAB\n9042216BAB\n9090608BAB\n0011803BAB\n2100501AAA\n8042705BAB\n8110501BAB\n9050818BAB\n9091301BAB\n0011804BAB\n2100706AAA\n8051101BAB\n8110514BAB\n9050909BAB\n9091302BAB\n0011804BAC\n7090112BAB\n8051101BAC\n8110915BAB\n9050909BAC\n9100117BAB\n0012003BAB\n7090112BAC\n8051107BAB\n8111511BAB\n9051008BAB\n9100126BAB\n0012020BAB\n7090516BAB\n8071601BAB\n8111511BAC\n9070807BAB\n9100301BAB\n0012024BAB\n7090516BAC\n8071701BAB\n9022011BAB\n9070808BAB\n9100302BAB\n1100707AAA\n7090701BAB\n8071902BAB\n9022011BAC\n9070808BAC\n9100705BAB\n1100819AAA\n7090902BAC\n8071902BAC\n9030206BAB\n9082301BAB\n9101803BAB\n1101108AAA\n7091506BAB\n8072623BAB\n9030207BAB\n9082302BAB\n1101109AAA\n7091603BAB\n8072626BAB\n9030412BAB\n9082613BAB\n\nMC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset / 81225809289\nLot Numbers:\n0011023BAB\n0012201BAB\n1102706AAA\n2092107AAA\n9101701BAB\n9122401BAB\n0012101BAB\n0012202BAB\n1102711AAA\n2092108AAA\n9111310BAB\n9122709BAB\n0012101BAC\n0012910BAB\n1110815AAA\n9101516BAC\n9112214BAB\n0012102BAB\n0012922BAB\n1110818AAA\n9101612BAB\n9112216BAB\n0012128BAB\n0013001BAB\n1111602AAA\n9101612BAC\n9122337BAB\n0012129BAB\n0013002BAB\n1113040AAA\n9101613BAB\n9122338BAB", "firm_fei_number": "3006179046", "recalling_firm": "NuVasive Specialized Orthopedics, Inc.", "address_1": "101 Enterprise Ste 100 101 Enterprise", "address_2": "Ste 100", "city": "Aliso Viejo", "state": "CA", "postal_code": "92656-2604", "additional_info_contact": "Patrick Yrigoyen\n858-344-2667", "reason_for_recall": "During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.", "root_cause_description": "Process control", "action": "On 11/01/2022, the firm sent an URGENT VOLUNTARY MEDICAL DEVICE RECALL Letter via Docusign/FedEx/email to customers (US/OUS Surgeons and Distributors) informing them that the packaging closure integrity (manufactured with an undersized O-ring of the MAGEC 2 (marketed as MAGEC X) packaged units. As a result of the undersized O-ring gland diameter, the O-ring compression is affected when the hard cap if affixed to the packaging tube. The lack of compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system.\n\nCustomer are instructed to:\n1. Immediately quarantine any affected product.\n2. Return all affected products. The NuVasive sales representative will be contacting customers to assist with the return actions.\n3. Review this notification to ensure that affected personnel are aware of its contents.\n4. For any devices that have been implanted, there are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedules.\n\nFor questions or assistance - contact Sr. Director, Global Quality at 858-344-2667, email pyrigoyen@nuvasive.com, or the NuVasive Sales Representative.", "product_quantity": "1,873 units", "distribution_pattern": "Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.", "openfda": { "k_number": [ "K171791", "K140613", "K161751", "K160352", "K233593", "K201543", "K150885", "K140178", "K141278" ], "registration_number": [ "3009973505", "3006179046", "1221763", "3006791286", "3005497913", "2029275", "3010047454", "3006128100", "3016438694", "2022435", "3003935342", "1835251", "3009144915" ], "fei_number": [ "3000205591", "1000306431", "3009973505", "3006179046", "1221763", "3006791286", "3005497913", "3010047454", "3006128100", "3016438694", "2022435", "3003935342", "3009144915" ], "device_name": "Growing Rod System- Magnetic Actuation", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3070", "device_class": "2" } } ] }