Reported May 13, 2020 · Terminated
NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use…
NuVasive 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 Inc · 7475 Lusk Blvd · San Diego, CA · 92121-5707
Is this the product you have?
NUVASIVE MAGEC 2 Rod X.X mm XX mmREF MC2-XXXXS
- LOT 0000000 AAA - Product Usagecomprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user)
- Lot codes and dates
- Part NumberMC2-4570R
- Product
MAGEC 2 ROD4.5mm 70mmOFFSET
- Lot Numbers
68 of 68 codes
8061403AAA8061411AAA8061419AAA8061419AAB8061508AAA8061808AAA8061809AAA8062301AAA8062602AAA8062705AAA8062810AAA8062810AAB8063003AAA8063011AAA8072409AAA8072501AAA8072505AAA8072627AAA8072628AAA8080805AAA8081102AAA8092609AAA8100810AAA8101905AAA8102003AAA8103165AAA8110306AAA8111202AAA8111504AAA8111508AAA8122101AAA8122610AAA9011102AAA9011428AAA9011429AAA9021601AAA9021603AAA9022703AAA9031511AAA9031601AAA9032002AAA9032901AAA9032914AAA9032915AAA9042508AAA9042601AAA9070104AAA9070112AAA9071114AAA9071521AAA9071610AAA9071617AAA9072215AAA9072701AAA9072702AAA9072705AAA9073001AAA9073022AAA9081501AAA9081502AAA
- Part NumberMC2-4570S
- Product
MAGEC 2 ROD4.5mm 70mmSTANDARD
- Lot Numbers
108 of 108 codes
8060727AAA8061101AAA8061106AAA8061203AAA8061204AAA8061213AAA8061214AAA8061218AAA8061318AAA8062307AAA8062622AAA8062713AAA8062902AAA8063005AAA8070206AAA8071001AAA8071118AAA8071208AAA8072508AAA8072510AAA8080703AAA8080902AAA8081001AAA8081010AAA8081011AAA8081012AAA8091324AAA8091401AAA8091401AAB8091404AAA8091701AAA8092738AAA8100803AAA8101015AAA8101901AAA8102902AAA8102902AAB8102910AAA8110505AAA8111322AAA8111325AAA8111414AAA8112108AAA8120727AAA8120902AAA8121328AAA8121904AAA8121913AAA9011112AAA9011502AAA9011601AAA9011611AAA9011627AAA9011712AAA9030102AAA9030104AAA9030111AAA9021401AAA9021402AAA9021404AAA
- Part NumberMC2-4590R
- Product
MAGEC 2 ROD4.5mm 90mmOFFSET
- Lot Numbers
62 of 62 codes
0010301AAA0010333AAA0010334AAA0010818AAA8062009AAA8062101AAA8062107AAA8062118AAA8062123AAA8062125AAA8070211AAA8070601AAA8070701AAA8070702AAA8071113AAA8071116AAA8072518AAA8072520AAA8073004AAA8080706AAA8081313AAA8082802AAA8082903AAA8090705AAA8091005AAA8091118AAA8091122AAA8092414AAA8092508AAA8100505AAA8111411AAA8121813AAA9010909AAA9012422AAA9022811AAA9032503AAA9051306AAA9051407AAA9051411AAA9051419AAA9061712AAA9061722AAA9062801AAA9062802AAA9062803AAA9062819AAA9071201AAA9071717AAA9072003AAA9072004AAA9072706AAA9073023AAA9080814AAA9080815AAA9081901AAA9081902AAA9081911AAA9092011AAA9121310AAA9121311AAA
- Part NumberMC2-4590S
- Product
MAGEC 2 ROD4.5mm 90mmSTANDARD
- Lot Numbers
103 of 103 codes
8060409AAA8060601AAA8061910AAA8061921AAA8061931AAA8061932AAA8062001AAA8062014AAA8062318AAA8062625AAA8070223AAA8070615AAA8070901AAA8070902AAA8071204AAA8071213AAA8071706AAA8071907AAA8072105AAA8082309AAA8082311AAA8082313AAA8082401AAA8082410AAA8082419AAA8082701AAA8082713AAA8082718AAA8082814AAA8090402AAA8090709AAA8091013AAA8092007AAA8092102AAA8092402AAA8092404AAA8100305AAA8100410AAA8111306AAA8111415AAA8111421AAA8121109AAA8121111AAA8121205AAA8121211AAA8121214AAA8121312AAA8121406AAA9010806AAA9011803AAA9011812AAA9020405AAA9021216AAA9021306AAA9021302AAA9022204AAA9031107AAA9031814AAA9032005AAA9032006AAA
- Part NumberMC2-5070R
- Product
MAGEC 2 ROD5.0mm 70mmOFFSET
- Lot Numbers
68 of 68 codes
0011023AAA0012101AAA0012102AAA0012128AAA0012129AAA0012201AAA0012202AAA0012910AAA0012922AAA0013001AAA0013002AAA8111511AAA9022011AAA9030412AAA9030415AAA9030504AAA7080101AAA7083002AAA7090517AAA7090608AAA7090903AAA7091514AAA7091604AAA7092101AAA7100501AAA7101310AAA7112214AAA7121218AAA8030603AAA8042406AAA8042704AAA9030205AAA8043013AAA8050804AAA8052201AAA8102504AAA8102511AAA8103001AAA8103102AAA8110621AAA8110703AAA9041817AAA9041906AAA9041918AAA9050905AAA9050907AAA9062729AAA9090517AAA9090518AAA9090609AAA9093018AAA9100115AAA9100116AAA9101501AAA9101502AAA9101514AAA9101516AAA9101516AAB9101612AAA9101613AAA
- Part NumberMC2-5070S
- Product
MAGEC 2 ROD5.0mm 70mmSTANDARD
- Lot Numbers
89 of 89 codes
0010742AAA0010743AAA0010770AAA0010771AAA0010773AAA0011643AAA0011644AAA0011714AAA0011715AAA0011803AAA0011804AAA0012003AAA0012020AAA0012024AAA7080701AAA7083001AAA7090112AAA7090516AAA7090701AAA7090902AAA7091506AAA7091603AAA7092303AAA7092605AAA7092802AAA7100409AAA7101309AAA7112003AAA7112803AAA7121410AAA7121602AAA8041114AAA8042408AAA8042705AAA8050905AAA8051004AAA8051101AAA8051107AAA8051112AAA8062821AAA8071403AAA8071601AAA8071701AAA8071902AAA8072623AAA8072626AAA8080403AAA8080613AAA8091906AAA8091909AAA8100919AAA8102313AAA8102501AAA8103117AAA8103150AAA8110501AAA8110514AAA8110915AAA9030206AAA9030207AAA
- Part NumberMC2-5090R
- Product
MAGEC 2 ROD5.0mm 90mmOFFSET
- Lot Numbers
70 of 70 codes
0010403AAA0010404AAA0011317AAA0011318AAA0011319AAA0011401AAA0011402AAA0011506AAA0011524AAA0011525AAA0011601AAA0011602AAA7081001AAA7082502AAA7083108AAA7090110AAA7090805AAA7091602AAA7092302AAA7100401AAA7102501AAA7112002AAA7112213AAA7121411AAA8020716AAA8030601AAA8042507AAA8042804AAA8062818AAA8073105AAA8091403AAA8092702AAA8092702AAB8100818AAA8101159AAA8102314AAA8103027AAA8103050AAA8112008AAA8122112AAA8122606AAA9011103AAA9022001AAA9022114AAA9031406AAA9031414AAA9042301AAA9042305AAA9042308AAA9042308AAB9042309AAA9050902AAA9060107AAA9060604AAA9060611AAA9060614AAA9061412AAA9082216AAA9082305AAA9082306AAA
- Part NumberMC2-5090S
- Product
MAGEC 2 ROD5.0mm 90mmSTANDARD
- Lot Numbers
128 of 128 codes
7072701AAA7082501AAA7083105AAA7090111AAA7090702AAA7090806AAA7091505AAA7091601AAA7092214AAA7092301AAA7092506AAA7100219AAA7101604AAA7102419AAA7110102AAA7121217AAA7121601AAA8020207AAA8040902AAA8040917AAA8042603AAA8043003AAA8050908AAA8051003AAA8051201AAA8051402AAA8051501AAA8051511AAA8051511AAB8071032AAA8071101AAA8071105AAA8071709AAA8071801AAA8072110AAA8072421AAA8072421AAB8081610AAA8081701AAA8081714AAA8081715AAA8082002AAA8082111AAA8082805AAA8082902AAA8083006AAA8090609AAA8091801AAA8091806AAA8100403AAA8102209AAA8110104AAA8110515AAA8110601AAA8111254AAA8111901AAA8112026AAA8120903AAA8120904AAA8120905AAA
- Part NumberMC2-5570R
- Product
MAGEC 2 ROD5.5mm 70mmOFFSET
- Lot Numbers
8051804AAA8052101AAA8052105AAA8052308AAA8052309AAA8060705AAA8060723AAA8060724AAA8070303AAA8071304AAA8071316AAA8072701AAA8080705AAA8080705AAB8081408AAA8081416AAA8081511AAA8081602AAA8081713AAA8092602AAA8100811AAA8102201AAA8102212AAA8102503AAA8111908AAA8112015AAA8112112AAA8122110AAA8122607AAA9021606AAA9021607AAA9022102AAA9022814AAA9030707AAA9030810AAA9040114AAA9040201AAA9052304AAA9052316AAA9052321AAA9052406AAA9060306AAA9060309AAA9060317AAA9060703AAA9060707AAA9060714AAA9060804AAA9061006AAA9061018AAA9061032AAA9061105AAA9090444AAA9091804AAA9091805AAA9121316AAA9121317AAA
- Part NumberMC2-5570S
- Product
MAGEC 2 ROD5.5mm 70mmSTANDARD
- Lot Numbers
82 of 82 codes
0012222AAA0012301AAA0012302AAA0012304AAA0012317AAA0012318AAA0012401AAA0012415AAA0012419AAA0012713AAA0012714AAA0013115AAA0013116AAA8060103AAA8060503AAA8060611AAA8060613AAA8060702AAA8061323AAA8062017AAA8062121AAA8062124AAA8062322AAA8062628AAA8062718AAA8062905AAA8063010AAA8070502AAA8082017AAA8082022AAA8082105AAA8082201AAA8082204AAA8082213AAA8083008AAA8090401AAA8092608AAA8100809AAA8101904AAA8102306AAA8102320AAA8102323AAA8102411AAA8111603AAA8121051AAA8121056AAA8121060AAA8121330AAA9011903AAA9021502AAA9021520AAA9022605AAA9021405AAA9031410AAA9031901AAA9032810AAA9032812AAA9032814AAA9052120AAA9052121AAA
- Part NumberMC2-5590R
- Product
MAGEC 2 ROD5.5mm 90mmOFFSET
- Lot Numbers
74 of 74 codes
0010335AAA0010336AAA0012801AAA0012802AAA0012829AAA0012901AAA8060107AAA8060517AAA8060605AAA8060608AAA8062019AAA8062112AAA8070505AAA8071327AAA8071402AAA8071608AAA8071711AAA8071814AAA8071910AAA8072305AAA8073006AAA8080217AAA8080809AAA8081103AAA8081104AAA8082215AAA8083003AAA8090504AAA8090724AAA8091101AAA8091211AAA8091221AAA8091311AAA8091702AAA8092415AAA8092502AAA8092505AAA8100509AAA9010919AAA9012002AAA9012125AAA9012204AAA9012425AAA9021317AAA9022110AAA9022801AAA9032511AAA9032601AAA9032603AAA9032628AAA9032633AAA9051431AAA9051501AAA9051504AAA9051506AAA9051601AAA9051602AAA9051603AAA9060408AAA9060411AAA
- Part NumberMC2-5590S
- Product
MAGEC 2 ROD5.5mm 90mmSTANDARD
- Lot Numbers
126 of 126 codes
0010620AAA0010621AAA8050118AAA8050207AAA8050312AAA8050703AAA8060109AAA8061116AAA8061126AAA8061206AAA8061210AAA8062023AAA8062113AAA8062511AAA8062702AAA8062808AAA8062920AAA8070512AAA8072309AAA8072311AAA8073005AAA8080316AAA8080401AAA8080612AAA8080812AAA8080905AAA8081316AAA8081317AAA8081404AAA8081503AAA8081703AAA8082905AAA8083101AAA8090615AAA8091103AAA8092107AAA8092405AAA8092411AAA8100101AAA8100311AAA8100414AAA8101813AAA8110105AAA8110203AAA8110223AAA8111257AAA8112604AAA8112610AAA8120619AAA8120625AAA8120722AAA8121704AAA8121705AAA8121717AAA8121801AAA8121802AAA9012003AAA9012309AAA9012332AAA9012402AAA
- Part NumberMC2-6070R
- Product
MAGEC 2 ROD6.0mm 70mmOFFSET
- Lot Numbers
8041901AAA8042002AAA8042101AAA8042304AAA8042614AAA8043008AAA8051614AAA8073109AAA8082909AAA8090604AAA9081508AAA9082707AAA9112303AAA9120511AAA9120518AAA9120531AAA9120632AAA9120633AAA9121201AAA9121202AAA9122620AAA9122621AAA
- Part NumberMC2-6070S
- Product
MAGEC 2 ROD6.0mm 70mmSTANDARD
- Lot Numbers
8041808AAA8050203AAA8050303AAA8050401AAA8051711AAA8051715AAA8062828AAA8080101AAA8080402AAA8083007AAA8092001AAA8092012AAA8092014AAA9042611AAA9061503AAA9073115AAA9091803AAA9102401AAA9120510AAA9120517AAA9120521AAA9120526AAA9120528AAA9121203AAA9122334AAA9122602AAA
- Part NumberMC2-6090R
- Product
MAGEC 2 ROD6.0mm 90mmOFFEST
- Lot Numbers
0010401AAA0010402AAA8041646AAA8043010AAA8051105AAA8051203AAA8051205AAA8051409AAA8051503AAA8051601AAA8061303AAA8071214AAA8071219AAA8080103AAA8080112AAA8080202AAA8081508AAA8090508AAA8091011AAA8092703AAA8100533AAA8121902AAA8122106AAA9011002AAA9012209AAA9012424AAA9031821AAA9051624AAA9061510AAA9072222AAA9082004AAA9092001AAA9120414AAA9120519AAA9120901AAA9121015AAA9121309AAA
- Part NumberMC2-6090S
- Product
MAGEC 2 ROD6.0mm 90mmSTANDARD
- Lot NumbersReference "Attachment 4 NuVasive MAGEC X PN-Lot Numbers.xlsx" uploaded into Associated Documents
8041635AAA8042102AAA8042402AAA8042404AAA8042703AAA8050808AAA8071003AAA8071005AAA8071020AAA8072007AAA8072011AAA8072103AAA8072109AAA8080105AAA8080113AAA8080605AAA8081605AAA8081611AAA8082813AAA8091704AAA8091705AAA8091706AAA8091915AAA8100314AAA8120705AAA8121805AAA8121810AAA9010807AAA9021209AAA9022526AAA9022536AAA9031113AAA9031208AAA9051101AAA9051103AAA9051104AAA9071718AAA9072424AAA9100203AAA9100204AAA9100207AAA9112301AAA9120402AAA9120416AAA9120417AAA9120501AAA9120502AAA9121009AAA9121016AAA9121439AAA9121441AAA
- Amount recalled
- 3502 rods
Where it was sold
Why it was recalled
Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration.
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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