Reported Dec 21, 2022 · Ongoing
NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of…
NuVasive Specialized Orthopedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NuVasive Specialized Orthopedics, Inc. · 101 Enterprise Ste 100 · Aliso Viejo, CA · 92656-2604
Is this the product you have?
- NUVASIVE 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
- Lot codes and dates
- REF Model Numbers/NSO Item #/Product
- Description/UDI-DI Code
MC2-4590S / PA0684-001 / MAGEC 2 Rod4.5mm 90mm
- Standard / 812258022624 Lot Numbers/ PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm
112 of 112 codes
0013101BAB2091504AAA8091013BAB8121214BAD9031814BAB9061902BAB2082304AAA8060409BAB8092007BAB8121312BAB9032005BAB9061911BAB2082306AAA8060601BAB8092102BAB8121406BAB9032006BAB9061912BAB2082309AAA8061921BAB8092404BAB8121406BAC9032006BAC9061912BAC2082412AAA8070615BAB8100410BAB9010806BAB9032007BAB9062018BAB2091201AAA8070902BAB8100410BAC9011803BAB9032007BAC9062411BAB2091202AAA8071213BAB8111306BAB9011803BAC9032014BAB9062412BAB2091211AAA8071706BAB8111415BAB9020405BAB9032101BAB9062412BAC2091212AAA8072105BAB8121109BAB9021216BAB9032102BAB9062413BAB2091303AAA8082313BAB8121109BAC9021302BAB9051011BAC9062508BAB
- Standard / 812258022662 Lot Numbers/ PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm
145 of 145 codes
0010620BAB8070512BAB9071302BAB9090410BAC8121801BAC9032222BAB0010620BAC8080401BAB9071302BAC9091714BAB8121802BAB9041701BAB0010621BAB8080612BAB9071517BAB9091714BAC9012309BAB9041706BAB0013113BAB8080812BAB9072315BAB9091801BAB9012309BAC9041707BAB0013113BAC8081703BAB9072318BAB9111301BAB9012332BAB9050704BAB0013113BAD8091103BAB9072319BAB9111302BAB9012404BAB9050706BAB1041203AAA8092107BAB9072415BAB9111302BAC9012404BAC9050712BAB1041204AAA8092405BAB9072415BAC9111306BAB9012410BAB9050806BAB1050405AAA8092411BAB9072420BAB9112119BAB9030612BAB9051004BAB1100709AAA8100101BAB9072420BAC9112119BAC9030703BAB9070915BAB
- Offset / 812258022709 Lot Numbers/ PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm
1093019AAA1102826AAA2092814AAA8051503BAB8091011BAB9031821BAB1100710AAA1110503AAA2092815AAA8051601BAB8092703BAB9061510BAB1100710AAB1110504AAA2100407AAA8071214BAB8100533BAB9082004BAB1100817AAA1110802AAA2100605AAA8071219BAB8121902BAB9092001BAB1102715AAA1111605AAA2101113AAA8080103BAB9012209BAB9120901BAB1102801AAA1113011AAA8043010BAB8080103BAC9012209BAC9121309BAB1102818AAA1120210AAA8051205BAB8081508BAB9012424BAB1102824AAA1120336AAA8051409BAB8090508BAB9012424BACMC2-4590R
- Offset / 812258022631 Lot Numbers/ PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm
74 of 74 codes
0010301BAB8071116BAB8091005BAB9010909BAC9062803BAB9081901BAB0010333BAB8072518BAB8091005BAC9010909BAD9062819BAB9081902BAB0010818BAB8072518BAC8091118BAB9012422BAB9071201BAB9081911BAB1040502AAA8072520BAB8091118BAC9022811BAB9071717BAB9092011BAB1040804AAA8072520BAC8091122BAB9032503BAB9072003BAB9121310BAB1040805AAA8073004BAB8092414BAB9051306BAB9072004BAB9121311BAB8062009BAB8080706BAB8092414BAC9051407BAB9072706BAB9121311BAC8062101BAB8081313BAB8092508BAB9051411BAB9072706BAC9121312BAB8062107BAB8081313BAC8092508BAC9051419BAB9073023BAB8062125BAB8082802BAB8092508BAD9061712BAB9073023BAC8070701BAB8082903BAB
- Offset / 812258022679 Lot Numbers/ PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm
95 of 95 codes
0010335BAB2092204AAA8080809BAB9122001BAB9032601BAC9062107BAB0010335BAC2092206AAA8081103BAB8092415BAB9032603BAB9062403BAB0010336BAB8060107BAB8081104BAB8092415BAC9032628BAB9062403BAC0012801BAB8060517BAB8082215BAB8092502BAB9032633BAB9062622BAB0012801BAC8060605BAB8082215BAC8092505BAB9051431BAB9062622BAC0012802BAB8062019BAB8090504BAB8100509BAB9051501BAB9062622BAD0012802BAC8062112BAB8090724BAB9010919BAB9051504BAB9062623BAB0012829BAB8070505BAB8091101BAB9012002BAB9051506BAB9073007BAB0012901BAB8071327BAB8091211BAB9012002BAC9051506BAC9081401BAB1040602AAA8071608BAB8091221BAB9012125BAB9051601BAB9081402BAB
- Standard / 812258022716 Lot Numbers/ PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm
71 of 71 codes
1041303ZZZ1110111AAA2011419ZZZ8041635BAB8121810BAB9112301BAC1041304ZZZ1110206AAA2011702ZZZ8042402BAB9021209BAB9120402BAB1070605ZZZ1110207AAA2062812ZZZ8071005BAB9022526BAB9120416BAB1070606ZZZ1110208AAA2062813ZZZ8072011BAB9022536BAB9120417BAB1082317ZZZ1110901AAA2082410ZZZ8072103BAB9051103BAB9120501BAB1082318ZZZ1112310AAA2082411ZZZ8080113BAB9051104BAB9120502BAB1092843AAA1112315AAA2090607ZZZ8080605BAB9071718BAB9121009BAB1092928AAA1112907AAA2093015AAA8081605BAB9072424BAB9121016BAB1100711AAA1120615AAA2093018AAA8091704BAB9100203BAB9121441BAB1100818AAA1120803AAA2100401AAA8091705BAB9100204BAB9121441BAC
- Standard / 812258022600 Lot Numbers/ PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm
121 of 121 codes
1040802AAA2071816AAA8061318BAB8092738BAB9011712BAB9040110BAC1040803AAA2071901AAA8062307BAB8110505BAB9021401BAB9040110BAD2051606AAA2082605AAA8062622BAB8111322BAB9021402BAB9051701BAB2051945AAA2082901AAA8063005BAB8111414BAB9021404BAB9051801BAB2051946AAA2082902AAA8063005BAC8112108BAB9021404BAC9051802BAB2051947AAA2082906AAA8070206BAB8120727BAB9030102BAB9052008BAB2052001AAA2090808AAA8071001BAB8120902BAB9030104BAB9052010BAB2052303AAA2090810AAA8072508BAB8120902BAC9031501BAB9061124BAB2052513AAA2090815AAA8072510BAB8121328BAB9031501BAC9061125BAB2052514AAA2090902AAA8080902BAB8121904BAB9032708BAB9061126BAB
- Standard / 812258022648 Lot Numbers/ PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm
105 of 105 codes
0012222BAB1050406AAA8070502BAB9091116BAB8102323BAC9032814BAB0012222BAC2070616AAA8082017BAB9121401BAB8102411BAB9052120BAB0012301BAB8060103BAB8082017BAC9121437BAB8111603BAB9052121BAB0012302BAB8060503BAB8082022BAB9122102BAB8121051BAB9052122BAB0012304BAB8060611BAB8082022BAC9122603BAB8121051BAC9052209BAB0012317BAB8060613BAB8082105BAB8082204BAB8121056BAB9052210BAB0012318BAB8060702BAB8082105BAC8082213BAB8121060BAK9060413BAB0012401BAB8060702BAC8082201BAB8082213BAC8121330BAB9060413BAC0012415BAB8062017BAB8082201BAC8083008BAB9011903BAB9060516BAB0012419BAB8062121BAB9062003BAB8090401BAB9021405BAB9060516BAC
- Standard / 812258022686 Lot Numbers/ PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm
1101912AAA1102927AAA8041808BAB8080402BAB8092014BAC9120521BAB1102001AAA1102928AAA8050203BAB8083007BAB8092014BAD9120526BAB1102004AAA1110105AAA8050303BAB8083007BAC9042611BAB9120528BAB1102013AAA1110108AAA8050401BAB8092001BAB9061503BAB9121203BAB1102015AAA1110110AAA8051711BAB8092001BAC9073115BAB9122334BAB1102015AAB1110210AAA8051711BAC8092001BAD9091803BAB9122602BAB1102204AAA1112317AAA8051715BAB8092012BAB9102401BAB1102204AAB1113022AAA8062828BAB8092012BAC9120510BAB1102926AAA1120705AAA8080101BAB8092014BAB9120517BABMC2-4570R
- Offset / 812258022617 Lot Numbers/ PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm
61 of 61 codes
1040505AAA9011428BAC9032901BAB9071521BAB9073022BAB9091906BAB1040801AAA9011429BAB9032914BAB9071610BAB9073022BAC9112302BAB2092105AAA9011429BAC9032914BAC9071610BAC9073022BAD9121924BAB2092106AAA9021601BAB9032915BAB9071617BAB9081501BAB9121924BAC8111504BAB9021603BAB9032915BAC9072215BAB9081501BAC9121938BAB8111508BAB9022703BAB9042508BAB9072701BAB9081502BAB9121938BAC8122101BAB9031511BAB9042601BAB9072702BAB9081502BAC9121941BAB9011102BAB9031601BAB9070104BAB9072705BAB9082113BAB9121941BAC9011102BAC9032002BAB9070112BAB9073001BAB9082113BAC9122622BAB9011428BAB9032002BAC9071114BAB9073001BAC9091905BAB9122622BAC
- Offset / 812258022655 Lot Numbers/ PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm
74 of 74 codes
1040601AAA8081511BAC8102503BAC9022814BAB9060309BAB9090444BAB1040701AAA8081602BAB8111908BAB9030707BAB9060317BAB9090444BAC1040903AAA8081602BAC8111908BAC9030810BAB9060703BAB9091804BAB1040904AAA8081713BAB8112015BAB9040114BAB9060707BAB9091805BAB1050401AAA8092602BAB8112015BAC9040201BAB9060714BAB9091805BAD1050402AAA8092602BAC8112015BAD9052304BAB9060714BAC9121316BAB1100708AAA8100811BAB8112112BAB9052304BAC9060804BAB9121316BAC1100812AAA8100811BAC8112112BAC9052316BAB9060804BAC9121317BAB2070619AAA8100811BAD8122110BAB9052321BAB9061006BAB8072701BAB8102201BAB8122607BAB9052321BAC9061018BAB8081408BAB8102212BAB
- Offset / 812258022693 Lot Numbers/ PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm
1101510AAA1102014AAA1102506AAA1112901AAA9120518BAB9122620BAB1101801AAA1102101AAA1102510AAA1113008AAA9120531BAB9122620BAC1101802AAA1102103AAA1102511AAA1113050AAA9120632BAB9122621BAB1101803AAA1102106AAA1102716AAA1120161AAA9120633BAB9122621BAC1101909AAA1102206AAA1102925AAA9120511BAB9121202BABMC2-5090S
- Standard / 81225809265 Lot Numbers/ PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm
177 of 177 codes
1092841AAA2051323AAA9012301BAC2081708AAA7092301BAB9101610BAB1092842AAA2051325AAA9012301BAD2081801AAA7110102BAB9110107BAB1092851AAA2051617AAA9021802BAB2081804AAA8040917BAB9110107BAC1092852AAA2051701AAA9021807BAB2081812AAA8043003BAB9110107BAD1092926AAA2052308AAA9021903BAB2081814AAA8050908BAB9110108BAB1092927AAA2052408AAA9021906BAB2081902AAA8050908BAC9110108BAC1093017AAA2052409AAA9021908BAB2081907AAA8051511BAB9110110BAB1093018AAA2052410AAA9021908BAC2081909AAA8082002BAB9110401BAB1100702AAA2052512AAA9030521BAB2082219AAA8082002BAC9110401BAC1101110AAA2081533AAA9030610BAB2082222AAA8082805BAB9110401BAD
- Offset / 81225809272 Lot Numbers/ PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm
91 of 91 codes
0010403BAB0011601BAB7112002BAB8103050BAC9042308BAC9082306BAC0010404BAB0011602BAB7112213BAB8112008BAB9042309BAB9082706BAB0010404BAC1111601AAA8020716BAC8122606BAB9042309BAC9091201BAB0011317BAB1121305AAA8030601BAE9011103BAB9050902BAB9091202BAB0011317BAC2092203AAA8042507BAB9011103BAC9060107BAB9091202BAC0011318BAB2092612AAA8042804BAB9022001BAB9060107BAC9091317BAB0011319BAB2100304AAA8062818BAB9022114BAB9060604BAB9091317BAC0011319BAC2100503AAA8091403BAB9022114BAC9060604BAC9091318BAB0011401BAB2101007AAA8091403BAC9031406BAB9060611BAB9100333BAB0011402BAB2101201AAA8100818BAB9031406BAC9060614BAB9100333BAC
- Standard / 81225809296 Lot Numbers/ PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm
113 of 113 codes
0010742BAB1101111AAA7092303BAB8080403BAB9030415BAB9082614BAB0010743BAB1101205AAA7092605BAB8091906BAB9030504BAB9082701BAB0010770BAB1101206AAA7092605BAC8091909BAB9030504BAC9082701BAC0010771BAB1101303AAA7092802BAC8091909BAC9042001BAB9082702BAB0010773BAB1101904AAA7112003BAC8100919BAB9042002BAB9082704BAB0011643BAB1101905AAA7112803BAC8102313BAB9042004BAB9090511BAB0011644BAB2091604AAA7121410BAB8102501BAB9042209BAB9090511BAC0011714BAB2091905AAA8041114BAB8103117BAB9042214BAB9090512BAB0011715BAB2092201AAA8042408BAB8103150BAB9042216BAB9090608BAB0011803BAB2100501AAA8042705BAB8110501BAB9050818BAB9091301BAB
- Offset / 81225809289 Lot Numbers
0011023BAB0012201BAB1102706AAA2092107AAA9101701BAB9122401BAB0012101BAB0012202BAB1102711AAA2092108AAA9111310BAB9122709BAB0012101BAC0012910BAB1110815AAA9101516BAC9112214BAB0012102BAB0012922BAB1110818AAA9101612BAB9112216BAB0012128BAB0013001BAB1111602AAA9101612BAC9122337BAB0012129BAB0013002BAB1113040AAA9101613BAB9122338BAB
- Amount recalled
- 1,873 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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