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U.S. Department of Health and Human Services

Class 2 Device Recall MAGEC 2 (Marketed as MAGEC X)

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 Class 2 Device Recall MAGEC 2 (Marketed as MAGEC X)see related information
Date Initiated by FirmNovember 01, 2022
Date PostedDecember 14, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0559-2023
Recall Event ID 91125
510(K)NumberK201543 
Product Classification Growing rod system- magnetic actuation - Product Code PGN
ProductNUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset
Code Information REF Model Numbers/NSO Item #/Product Description/UDI-DI Code: MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard / 812258022624 Lot Numbers: 0013101BAB 2091504AAA 8091013BAB 8121214BAD 9031814BAB 9061902BAB 2082304AAA 8060409BAB 8092007BAB 8121312BAB 9032005BAB 9061911BAB 2082306AAA 8060601BAB 8092102BAB 8121406BAB 9032006BAB 9061912BAB 2082309AAA 8061921BAB 8092404BAB 8121406BAC 9032006BAC 9061912BAC 2082412AAA 8070615BAB 8100410BAB 9010806BAB 9032007BAB 9062018BAB 2091201AAA 8070902BAB 8100410BAC 9011803BAB 9032007BAC 9062411BAB 2091202AAA 8071213BAB 8111306BAB 9011803BAC 9032014BAB 9062412BAB 2091211AAA 8071706BAB 8111415BAB 9020405BAB 9032101BAB 9062412BAC 2091212AAA 8072105BAB 8121109BAB 9021216BAB 9032102BAB 9062413BAB 2091303AAA 8082313BAB 8121109BAC 9021302BAB 9051011BAC 9062508BAB 2091304AAA 8082401BAB 8121111BAB 9021306BAB 9051016BAB 9062517BAB 2091312AAA 8082410BAB 8121205BAB 9022204BAB 9051016BAC 9062519BAB 2091314AAA 8082701BAB 8121211BAB 9022204BAC 9061812BAB 9062520BAB 2091403AAA 8082814BAB 8121214BAB 9022204BAD 9061819BAB 9062702BAB 2091405AAA 8090709BAB 8121214BAC 9031107BAB 9061901BAB 9072313BAB 9072314BAB 9081307BAB 9090931BAC 9091002BAB 9121635BAB 9121719BAB 9072516BAB 9081312BAB 9090956BAB 9093010BAB 9121711BAB 9072601BAB 9090930BAB 9090956BAC 9111222BAB 9121712BAB 9080301BAB 9090931BAB 9091001BAB 9112013BAB 9121713BAB MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard / 812258022662 Lot Numbers: 0010620BAB 8070512BAB 9071302BAB 9090410BAC 8121801BAC 9032222BAB 0010620BAC 8080401BAB 9071302BAC 9091714BAB 8121802BAB 9041701BAB 0010621BAB 8080612BAB 9071517BAB 9091714BAC 9012309BAB 9041706BAB 0013113BAB 8080812BAB 9072315BAB 9091801BAB 9012309BAC 9041707BAB 0013113BAC 8081703BAB 9072318BAB 9111301BAB 9012332BAB 9050704BAB 0013113BAD 8091103BAB 9072319BAB 9111302BAB 9012404BAB 9050706BAB 1041203AAA 8092107BAB 9072415BAB 9111302BAC 9012404BAC 9050712BAB 1041204AAA 8092405BAB 9072415BAC 9111306BAB 9012410BAB 9050806BAB 1050405AAA 8092411BAB 9072420BAB 9112119BAB 9030612BAB 9051004BAB 1100709AAA 8100101BAB 9072420BAC 9112119BAC 9030703BAB 9070915BAB 2070513AAA 8100414BAB 9072421BAB 9112201BAB 9030823BAB 9070916BAB 2070515AAA 8101813BAB 9072421BAC 9112201BAC 9030826BAB 9071111BAB 2070611AAA 8110105BAB 9080812BAB 9112209BAB 9030901BAB 9071208BAB 2082413AAA 8111257BAB 9080812BAC 9112209BAC 9030902BAB 9071209BAB 2082415AAA 8111257BAC 9080812BAD 9112209BAD 9030904BAB 9071209BAC 2082501AAA 8112604BAB 9080812BAE 9112210BAB 9031102BAB 9120306BAB 2082603AAA 8112604BAC 9080813BAB 9112211BAB 9032119BAB 9120307BAB 2082604AAA 8112610BAB 9081301BAB 9112523BAB 9032119BAC 9120401BAB 2092301AAA 8112610BAC 9081917BAB 8120625BAB 9032120BAB 9120401BAC 8050703BAB 8120619BAB 9081917BAC 8120722BAB 9032205BAB 9120401BAD 8062113BAB 8120619BAC 9082601BAB 8121704BAB 9032212BAB 9121809BAB 8062511BAB 9071209BAD 9082601BAC 8121705BAB 9032213BAB 9121810BAB 8062702BAB 9071301BAB 9082602BAB 8121717BAB 9032217BAB 9121815BAB 8062808BAB 9071301BAC 9090410BAB 8121801BAB 9032217BAC 9121815BAC MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset / 812258022709 Lot Numbers: 1093019AAA 1102826AAA 2092814AAA 8051503BAB 8091011BAB 9031821BAB 1100710AAA 1110503AAA 2092815AAA 8051601BAB 8092703BAB 9061510BAB 1100710AAB 1110504AAA 2100407AAA 8071214BAB 8100533BAB 9082004BAB 1100817AAA 1110802AAA 2100605AAA 8071219BAB 8121902BAB 9092001BAB 1102715AAA 1111605AAA 2101113AAA 8080103BAB 9012209BAB 9120901BAB 1102801AAA 1113011AAA 8043010BAB 8080103BAC 9012209BAC 9121309BAB 1102818AAA 1120210AAA 8051205BAB 8081508BAB 9012424BAB 1102824AAA 1120336AAA 8051409BAB 8090508BAB 9012424BAC MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset / 812258022631 Lot Numbers: 0010301BAB 8071116BAB 8091005BAB 9010909BAC 9062803BAB 9081901BAB 0010333BAB 8072518BAB 8091005BAC 9010909BAD 9062819BAB 9081902BAB 0010818BAB 8072518BAC 8091118BAB 9012422BAB 9071201BAB 9081911BAB 1040502AAA 8072520BAB 8091118BAC 9022811BAB 9071717BAB 9092011BAB 1040804AAA 8072520BAC 8091122BAB 9032503BAB 9072003BAB 9121310BAB 1040805AAA 8073004BAB 8092414BAB 9051306BAB 9072004BAB 9121311BAB 8062009BAB 8080706BAB 8092414BAC 9051407BAB 9072706BAB 9121311BAC 8062101BAB 8081313BAB 8092508BAB 9051411BAB 9072706BAC 9121312BAB 8062107BAB 8081313BAC 8092508BAC 9051419BAB 9073023BAB 8062125BAB 8082802BAB 8092508BAD 9061712BAB 9073023BAC 8070701BAB 8082903BAB 8100505BAB 9061722BAB 9080814BAB 8070702BAB 8090705BAB 8111411BAB 9062801BAB 9080814BAC 8071113BAB 8090705BAC 8121813BAB 9062802BAB 9080815BAB MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset / 812258022679 Lot Numbers: 0010335BAB 2092204AAA 8080809BAB 9122001BAB 9032601BAC 9062107BAB 0010335BAC 2092206AAA 8081103BAB 8092415BAB 9032603BAB 9062403BAB 0010336BAB 8060107BAB 8081104BAB 8092415BAC 9032628BAB 9062403BAC 0012801BAB 8060517BAB 8082215BAB 8092502BAB 9032633BAB 9062622BAB 0012801BAC 8060605BAB 8082215BAC 8092505BAB 9051431BAB 9062622BAC 0012802BAB 8062019BAB 8090504BAB 8100509BAB 9051501BAB 9062622BAD 0012802BAC 8062112BAB 8090724BAB 9010919BAB 9051504BAB 9062623BAB 0012829BAB 8070505BAB 8091101BAB 9012002BAB 9051506BAB 9073007BAB 0012901BAB 8071327BAB 8091211BAB 9012002BAC 9051506BAC 9081401BAB 1040602AAA 8071608BAB 8091221BAB 9012125BAB 9051601BAB 9081402BAB 1041201AAA 8071711BAB 8091221BAC 9012425BAB 9051602BAB 9081412BAB 1041202AAA 8071814BAB 8091702BAB 9022110BAB 9051603BAB 9081417BAB 1050404AAA 8071910BAB 8091702BAC 9022801BAB 9060408BAB 9081417BAC 1050407AAA 8072305BAB 9112019BAB 9022801BAC 9060408BAC 9081601BAB 2070519AAA 8073006BAB 9112020BAB 9032511BAB 9060411BAB 2070606AAA 8080217BAB 9112020BAC 9032601BAB 9062106BAB MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard / 812258022716 Lot Numbers: 1041303ZZZ 1110111AAA 2011419ZZZ 8041635BAB 8121810BAB 9112301BAC 1041304ZZZ 1110206AAA 2011702ZZZ 8042402BAB 9021209BAB 9120402BAB 1070605ZZZ 1110207AAA 2062812ZZZ 8071005BAB 9022526BAB 9120416BAB 1070606ZZZ 1110208AAA 2062813ZZZ 8072011BAB 9022536BAB 9120417BAB 1082317ZZZ 1110901AAA 2082410ZZZ 8072103BAB 9051103BAB 9120501BAB 1082318ZZZ 1112310AAA 2082411ZZZ 8080113BAB 9051104BAB 9120502BAB 1092843AAA 1112315AAA 2090607ZZZ 8080605BAB 9071718BAB 9121009BAB 1092928AAA 1112907AAA 2093015AAA 8081605BAB 9072424BAB 9121016BAB 1100711AAA 1120615AAA 2093018AAA 8091704BAB 9100203BAB 9121441BAB 1100818AAA 1120803AAA 2100401AAA 8091705BAB 9100204BAB 9121441BAC 1102709ZZZ 1120910AAA 2100701AAA 8120705BAB 9100207BAB 1102710ZZZ 1120914AAA 2101114AAA 8121805BAB 9112301BAB MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard / 812258022600 Lot Numbers: 1040802AAA 2071816AAA 8061318BAB 8092738BAB 9011712BAB 9040110BAC 1040803AAA 2071901AAA 8062307BAB 8110505BAB 9021401BAB 9040110BAD 2051606AAA 2082605AAA 8062622BAB 8111322BAB 9021402BAB 9051701BAB 2051945AAA 2082901AAA 8063005BAB 8111414BAB 9021404BAB 9051801BAB 2051946AAA 2082902AAA 8063005BAC 8112108BAB 9021404BAC 9051802BAB 2051947AAA 2082906AAA 8070206BAB 8120727BAB 9030102BAB 9052008BAB 2052001AAA 2090808AAA 8071001BAB 8120902BAB 9030104BAB 9052010BAB 2052303AAA 2090810AAA 8072508BAB 8120902BAC 9031501BAB 9061124BAB 2052513AAA 2090815AAA 8072510BAB 8121328BAB 9031501BAC 9061125BAB 2052514AAA 2090902AAA 8080902BAB 8121904BAB 9032708BAB 9061126BAB 2070801AAA 2090903AAA 8081001BAB 8121904BAC 9032711BAB 9061220BAB 2070803AAA 2090906AAA 8091324BAB 9011601BAB 9032714BAB 9061221BAB 2071102AAA 2090917AAA 8091404BAB 9011611BAB 9032801BAB 9061221BAC 2071808AAA 8061203BAB 8091404BAC 9011611BAC 9032807BAB 9061221BAD 2071811AAA 8061218BAB 8091701BAB 9011627BAB 9040110BAB 9071726BAB 9071727BAB 9082101BAB 9091601BAB 9091701BAB 9092417BAB 9112016BAB 9071732BAB 9082101BAC 9091619BAB 9091702BAB 9093011BAB 9112017BAB 9071826BAB 9082102BAB 9091620BAB 9091712BAB 9100701BAB 9122059BAB 9071905BAB 9090438BAB 9091620BAC 9092414BAB 9112014BAB 9122063BAB 9071906BAB 9090438BAC 9091620BAD 9092415BAB 9112015BAB 9122101BAB MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard / 812258022648 Lot Numbers: 0012222BAB 1050406AAA 8070502BAB 9091116BAB 8102323BAC 9032814BAB 0012222BAC 2070616AAA 8082017BAB 9121401BAB 8102411BAB 9052120BAB 0012301BAB 8060103BAB 8082017BAC 9121437BAB 8111603BAB 9052121BAB 0012302BAB 8060503BAB 8082022BAB 9122102BAB 8121051BAB 9052122BAB 0012304BAB 8060611BAB 8082022BAC 9122603BAB 8121051BAC 9052209BAB 0012317BAB 8060613BAB 8082105BAB 8082204BAB 8121056BAB 9052210BAB 0012318BAB 8060702BAB 8082105BAC 8082213BAB 8121060BAK 9060413BAB 0012401BAB 8060702BAC 8082201BAB 8082213BAC 8121330BAB 9060413BAC 0012415BAB 8062017BAB 8082201BAC 8083008BAB 9011903BAB 9060516BAB 0012419BAB 8062121BAB 9062003BAB 8090401BAB 9021405BAB 9060516BAC 0012713BAB 8062124BAB 9062004BAB 8092608BAB 9021502BAB 9061224BAB 0012714BAB 8062322BAB 9062005BAB 8100809BAB 9021520BAB 9061224BAC 0013115BAB 8062628BAB 9082001BAB 8100809BAC 9022605BAB 9061225BAB 0013116BAB 8062628BAC 9082002BAB 8101904BAB 9031410BAB 9061314BAB 1040702AAA 8062718BAB 9082933BAB 8102306BAB 9031901BAB 1040905AAA 8062905BAB 9083001BAB 8102306BAC 9032810BAB 1040906AAA 8062905BAC 9091019BAB 8102320BAB 9032810BAC 1050403AAA 8063010BAB 9091021BAB 8102323BAB 9032812BAB MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard / 812258022686 Lot Numbers: 1101912AAA 1102927AAA 8041808BAB 8080402BAB 8092014BAC 9120521BAB 1102001AAA 1102928AAA 8050203BAB 8083007BAB 8092014BAD 9120526BAB 1102004AAA 1110105AAA 8050303BAB 8083007BAC 9042611BAB 9120528BAB 1102013AAA 1110108AAA 8050401BAB 8092001BAB 9061503BAB 9121203BAB 1102015AAA 1110110AAA 8051711BAB 8092001BAC 9073115BAB 9122334BAB 1102015AAB 1110210AAA 8051711BAC 8092001BAD 9091803BAB 9122602BAB 1102204AAA 1112317AAA 8051715BAB 8092012BAB 9102401BAB 1102204AAB 1113022AAA 8062828BAB 8092012BAC 9120510BAB 1102926AAA 1120705AAA 8080101BAB 8092014BAB 9120517BAB MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset / 812258022617 Lot Numbers: 1040505AAA 9011428BAC 9032901BAB 9071521BAB 9073022BAB 9091906BAB 1040801AAA 9011429BAB 9032914BAB 9071610BAB 9073022BAC 9112302BAB 2092105AAA 9011429BAC 9032914BAC 9071610BAC 9073022BAD 9121924BAB 2092106AAA 9021601BAB 9032915BAB 9071617BAB 9081501BAB 9121924BAC 8111504BAB 9021603BAB 9032915BAC 9072215BAB 9081501BAC 9121938BAB 8111508BAB 9022703BAB 9042508BAB 9072701BAB 9081502BAB 9121938BAC 8122101BAB 9031511BAB 9042601BAB 9072702BAB 9081502BAC 9121941BAB 9011102BAB 9031601BAB 9070104BAB 9072705BAB 9082113BAB 9121941BAC 9011102BAC 9032002BAB 9070112BAB 9073001BAB 9082113BAC 9122622BAB 9011428BAB 9032002BAC 9071114BAB 9073001BAC 9091905BAB 9122622BAC MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset / 812258022655 Lot Numbers: 1040601AAA 8081511BAC 8102503BAC 9022814BAB 9060309BAB 9090444BAB 1040701AAA 8081602BAB 8111908BAB 9030707BAB 9060317BAB 9090444BAC 1040903AAA 8081602BAC 8111908BAC 9030810BAB 9060703BAB 9091804BAB 1040904AAA 8081713BAB 8112015BAB 9040114BAB 9060707BAB 9091805BAB 1050401AAA 8092602BAB 8112015BAC 9040201BAB 9060714BAB 9091805BAD 1050402AAA 8092602BAC 8112015BAD 9052304BAB 9060714BAC 9121316BAB 1100708AAA 8100811BAB 8112112BAB 9052304BAC 9060804BAB 9121316BAC 1100812AAA 8100811BAC 8112112BAC 9052316BAB 9060804BAC 9121317BAB 2070619AAA 8100811BAD 8122110BAB 9052321BAB 9061006BAB 8072701BAB 8102201BAB 8122607BAB 9052321BAC 9061018BAB 8081408BAB 8102212BAB 9021606BAB 9052406BAB 9061032BAB 8081416BAB 8102212BAC 9021607BAB 9052406BAC 9061105BAB 8081511BAB 8102503BAB 9022102BAB 9060306BAB 9061105BAC MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset / 812258022693 Lot Numbers: 1101510AAA 1102014AAA 1102506AAA 1112901AAA 9120518BAB 9122620BAB 1101801AAA 1102101AAA 1102510AAA 1113008AAA 9120531BAB 9122620BAC 1101802AAA 1102103AAA 1102511AAA 1113050AAA 9120632BAB 9122621BAB 1101803AAA 1102106AAA 1102716AAA 1120161AAA 9120633BAB 9122621BAC 1101909AAA 1102206AAA 1102925AAA 9120511BAB 9121202BAB MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard / 81225809265 Lot Numbers: 1092841AAA 2051323AAA 9012301BAC 2081708AAA 7092301BAB 9101610BAB 1092842AAA 2051325AAA 9012301BAD 2081801AAA 7110102BAB 9110107BAB 1092851AAA 2051617AAA 9021802BAB 2081804AAA 8040917BAB 9110107BAC 1092852AAA 2051701AAA 9021807BAB 2081812AAA 8043003BAB 9110107BAD 1092926AAA 2052308AAA 9021903BAB 2081814AAA 8050908BAB 9110108BAB 1092927AAA 2052408AAA 9021906BAB 2081902AAA 8050908BAC 9110108BAC 1093017AAA 2052409AAA 9021908BAB 2081907AAA 8051511BAB 9110110BAB 1093018AAA 2052410AAA 9021908BAC 2081909AAA 8082002BAB 9110401BAB 1100702AAA 2052512AAA 9030521BAB 2082219AAA 8082002BAC 9110401BAC 1101110AAA 2081533AAA 9030610BAB 2082222AAA 8082805BAB 9110401BAD 1101307AAA 2081537AAA 9040102BAB 2082302AAA 8082805BAC 9110407BAB 1101309AAA 2081630AAA 9041005BAB 2083004AAA 8083006BAB 9110408BAB 1101313AAA 2081635AAA 9041005BAC 2083005AAA 8083006BAC 9110408BAC 1101409AAA 2081701AAA 9041008BAB 2083007AAA 8091806BAB 9110901BAB 1101410AAA 2081703AAA 9042412BAB 2083008AAA 8110104BAB 9110902BAB 1101413AAA 8110515BAB 9042414BAB 2083101AAA 9061106BAB 9110903BAB 1110306AAA 8110515BAC 9042501BAB 2090101AAA 9061120BAB 9110904BAB 1110307AAA 8111901BAB 9050819BAB 2090120AAA 9061120BAC 9111109BAB 1110308AAA 8120903BAB 9052408BAB 2090122AAA 9061310BAB 9111110BAB 1110405AAA 8120904BAB 9052409BAB 2090123AAA 9082202BAB 9112021BAB 1110406AAA 8120905BAB 9052804BAB 2092701AAA 9082202BAD 9112022BAB 1110410AAA 8121923BAB 9052805BAB 2092710AAA 9082801BAB 9112023BAB 1110501AAA 8122007BAB 9052805BAC 2100406AAA 9082802BAB 9112023BAC 1112408AAA 8122011BAB 9052816BAB 2100601AAA 9101401BAB 9112101BAB 1112910AAA 8122011BAC 9052816BAC 2101101AAA 9101403BAB 9112102BAB 1120164AAA 9010801BAB 9052817BAB 2101301AAA 9101403BAC 9112611BAB 1120708AAA 9011114BAB 9052817BAC 7083105BAB 9101415BAB 2051203AAA 9011816BAB 9053025BAB 7090806BAB 9101416BAB 2051204AAA 9011816BAC 9053112BAB 7091505BAB 9101601BAB 2051205AAA 9012301BAB 9060105BAB 7092214BAB 9101601BAC MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset / 81225809272 Lot Numbers: 0010403BAB 0011601BAB 7112002BAB 8103050BAC 9042308BAC 9082306BAC 0010404BAB 0011602BAB 7112213BAB 8112008BAB 9042309BAB 9082706BAB 0010404BAC 1111601AAA 8020716BAC 8122606BAB 9042309BAC 9091201BAB 0011317BAB 1121305AAA 8030601BAE 9011103BAB 9050902BAB 9091202BAB 0011317BAC 2092203AAA 8042507BAB 9011103BAC 9060107BAB 9091202BAC 0011318BAB 2092612AAA 8042804BAB 9022001BAB 9060107BAC 9091317BAB 0011319BAB 2100304AAA 8062818BAB 9022114BAB 9060604BAB 9091317BAC 0011319BAC 2100503AAA 8091403BAB 9022114BAC 9060604BAC 9091318BAB 0011401BAB 2101007AAA 8091403BAC 9031406BAB 9060611BAB 9100333BAB 0011402BAB 2101201AAA 8100818BAB 9031406BAC 9060614BAB 9100333BAC 0011402BAC 7083108BAB 8101159BAB 9031406BAD 9061412BAB 9100334BAB 0011506BAB 7091602BAB 8102314BAB 9031414BAB 9082216BAB 9100407BAB 0011524BAB 7092302BAB 8102314BAC 9042301BAB 9082216BAC 9100408BAB 0011525BAB 7100401BAB 8103027BAB 9042305BAB 9082305BAB 9121402BAB 0011525BAC 7102501BAB 8103050BAB 9042308BAB 9082306BAB 9121402BAC MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard / 81225809296 Lot Numbers: 0010742BAB 1101111AAA 7092303BAB 8080403BAB 9030415BAB 9082614BAB 0010743BAB 1101205AAA 7092605BAB 8091906BAB 9030504BAB 9082701BAB 0010770BAB 1101206AAA 7092605BAC 8091909BAB 9030504BAC 9082701BAC 0010771BAB 1101303AAA 7092802BAC 8091909BAC 9042001BAB 9082702BAB 0010773BAB 1101904AAA 7112003BAC 8100919BAB 9042002BAB 9082704BAB 0011643BAB 1101905AAA 7112803BAC 8102313BAB 9042004BAB 9090511BAB 0011644BAB 2091604AAA 7121410BAB 8102501BAB 9042209BAB 9090511BAC 0011714BAB 2091905AAA 8041114BAB 8103117BAB 9042214BAB 9090512BAB 0011715BAB 2092201AAA 8042408BAB 8103150BAB 9042216BAB 9090608BAB 0011803BAB 2100501AAA 8042705BAB 8110501BAB 9050818BAB 9091301BAB 0011804BAB 2100706AAA 8051101BAB 8110514BAB 9050909BAB 9091302BAB 0011804BAC 7090112BAB 8051101BAC 8110915BAB 9050909BAC 9100117BAB 0012003BAB 7090112BAC 8051107BAB 8111511BAB 9051008BAB 9100126BAB 0012020BAB 7090516BAB 8071601BAB 8111511BAC 9070807BAB 9100301BAB 0012024BAB 7090516BAC 8071701BAB 9022011BAB 9070808BAB 9100302BAB 1100707AAA 7090701BAB 8071902BAB 9022011BAC 9070808BAC 9100705BAB 1100819AAA 7090902BAC 8071902BAC 9030206BAB 9082301BAB 9101803BAB 1101108AAA 7091506BAB 8072623BAB 9030207BAB 9082302BAB 1101109AAA 7091603BAB 8072626BAB 9030412BAB 9082613BAB MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset / 81225809289 Lot Numbers: 0011023BAB 0012201BAB 1102706AAA 2092107AAA 9101701BAB 9122401BAB 0012101BAB 0012202BAB 1102711AAA 2092108AAA 9111310BAB 9122709BAB 0012101BAC 0012910BAB 1110815AAA 9101516BAC 9112214BAB 0012102BAB 0012922BAB 1110818AAA 9101612BAB 9112216BAB 0012128BAB 0013001BAB 1111602AAA 9101612BAC 9122337BAB 0012129BAB 0013002BAB 1113040AAA 9101613BAB 9122338BAB
Recalling Firm/
Manufacturer		 NuVasive Specialized Orthopedics, Inc.
101 Enterprise Ste 100
Aliso Viejo CA 92656-2604
For Additional Information ContactPatrick Yrigoyen
858-344-2667
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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. Customer are instructed to: 1. Immediately quarantine any affected product. 2. Return all affected products. The NuVasive sales representative will be contacting customers to assist with the return actions. 3. Review this notification to ensure that affected personnel are aware of its contents. 4. 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. For questions or assistance - contact Sr. Director, Global Quality at 858-344-2667, email pyrigoyen@nuvasive.com, or the NuVasive Sales Representative.
Quantity in Commerce1,873 units
DistributionDistribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PGN
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