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U.S. Department of Health and Human Services

Class 2 Device Recall NuVasive MAGEC Model X Rods

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  Class 2 Device Recall NuVasive MAGEC Model X Rods see related information
Date Initiated by Firm February 13, 2020
Create Date May 05, 2020
Recall Status1 Terminated 3 on May 25, 2022
Recall Number Z-1898-2020
Recall Event ID 85495
510(K)Number K171791  
Product Classification Growing rod system- magnetic actuation - Product Code PGN
Product NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised 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).
Code Information Part Number: MC2-4570R Product: MAGEC 2 ROD, 4.5mm 70mmOFFSET Lot Numbers: 8061403AAA 8061411AAA 8061419AAA 8061419AAB 8061508AAA 8061808AAA 8061809AAA 8062301AAA 8062602AAA 8062705AAA 8062810AAA 8062810AAB 8063003AAA 8063011AAA 8072409AAA 8072501AAA 8072505AAA 8072627AAA 8072628AAA 8080805AAA 8081102AAA 8092609AAA 8100810AAA 8101905AAA 8102003AAA 8103165AAA 8110306AAA 8111202AAA 8111504AAA 8111508AAA 8122101AAA 8122610AAA 9011102AAA 9011428AAA 9011429AAA 9021601AAA 9021603AAA 9022703AAA 9031511AAA 9031601AAA 9032002AAA 9032901AAA 9032914AAA 9032915AAA 9042508AAA 9042601AAA 9070104AAA 9070112AAA 9071114AAA 9071521AAA 9071610AAA 9071617AAA 9072215AAA 9072701AAA 9072702AAA 9072705AAA 9073001AAA 9073022AAA 9081501AAA 9081502AAA 9082113AAA 9091905AAA 9091906AAA 9112302AAA 9121924AAA 9121938AAA 9121941AAA 9122622AAA  Part Number: MC2-4570S Product: MAGEC 2 ROD, 4.5mm 70mmSTANDARD Lot Numbers: 8060727AAA 8061101AAA 8061106AAA 8061203AAA 8061204AAA 8061213AAA 8061214AAA 8061218AAA 8061318AAA 8062307AAA 8062622AAA 8062713AAA 8062902AAA 8063005AAA 8070206AAA 8071001AAA 8071118AAA 8071208AAA 8072508AAA 8072510AAA 8080703AAA 8080902AAA 8081001AAA 8081010AAA 8081011AAA 8081012AAA 8091324AAA 8091401AAA 8091401AAB 8091404AAA 8091701AAA 8092738AAA 8100803AAA 8101015AAA 8101901AAA 8102902AAA 8102902AAB 8102910AAA 8110505AAA 8111322AAA 8111325AAA 8111414AAA 8112108AAA 8120727AAA 8120902AAA 8121328AAA 8121904AAA 8121913AAA 9011112AAA 9011502AAA 9011601AAA 9011611AAA 9011627AAA 9011712AAA 9030102AAA 9030104AAA 9030111AAA 9021401AAA 9021402AAA 9021404AAA 9031501AAA 9032701AAA 9032704AAA 9032708AAA 9032711AAA 9032714AAA 9032801AAA 9032807AAA 9040110AAA 9051701AAA 9051708AAA 9051801AAA 9051802AAA 9051803AAA 9052008AAA 9052010AAA 9061124AAA 9061125AAA 9061126AAA 9061220AAA 9061221AAA 9071726AAA 9071727AAA 9071732AAA 9071826AAA 9071905AAA 9071906AAA 9082101AAA 9082102AAA 9090438AAA 9091601AAA 9091619AAA 9091620AAA 9091701AAA 9091702AAA 9091712AAA 9092414AAA 9092415AAA 9092417AAA 9093011AAA 9100701AAA 9112014AAA 9112015AAA 9112016AAA 9112017AAA 9122059AAA 9122063AAA 9122101AAA  Part Number: MC2-4590R  Product: MAGEC 2 ROD, 4.5mm 90mmOFFSET Lot Numbers: 0010301AAA 0010333AAA 0010334AAA 0010818AAA 8062009AAA 8062101AAA 8062107AAA 8062118AAA 8062123AAA 8062125AAA 8070211AAA 8070601AAA 8070701AAA 8070702AAA 8071113AAA 8071116AAA 8072518AAA 8072520AAA 8073004AAA 8080706AAA 8081313AAA 8082802AAA 8082903AAA 8090705AAA 8091005AAA 8091118AAA 8091122AAA 8092414AAA 8092508AAA 8100505AAA 8111411AAA 8121813AAA 9010909AAA 9012422AAA 9022811AAA 9032503AAA 9051306AAA 9051407AAA 9051411AAA 9051419AAA 9061712AAA 9061722AAA 9062801AAA 9062802AAA 9062803AAA 9062819AAA 9071201AAA 9071717AAA 9072003AAA 9072004AAA 9072706AAA 9073023AAA 9080814AAA 9080815AAA 9081901AAA 9081902AAA 9081911AAA 9092011AAA 9121310AAA 9121311AAA 9121311AAB 9121312AAA  Part Number: MC2-4590S  Product: MAGEC 2 ROD, 4.5mm 90mmSTANDARD Lot Numbers: 8060409AAA 8060601AAA 8061910AAA 8061921AAA 8061931AAA 8061932AAA 8062001AAA 8062014AAA 8062318AAA 8062625AAA 8070223AAA 8070615AAA 8070901AAA 8070902AAA 8071204AAA 8071213AAA 8071706AAA 8071907AAA 8072105AAA 8082309AAA 8082311AAA 8082313AAA 8082401AAA 8082410AAA 8082419AAA 8082701AAA 8082713AAA 8082718AAA 8082814AAA 8090402AAA 8090709AAA 8091013AAA 8092007AAA 8092102AAA 8092402AAA 8092404AAA 8100305AAA 8100410AAA 8111306AAA 8111415AAA 8111421AAA 8121109AAA 8121111AAA 8121205AAA 8121211AAA 8121214AAA 8121312AAA 8121406AAA 9010806AAA 9011803AAA 9011812AAA 9020405AAA 9021216AAA 9021306AAA 9021302AAA 9022204AAA 9031107AAA 9031814AAA 9032005AAA 9032006AAA 9032007AAA 9032014AAA 9032101AAA 9032102AAA 9051011AAA 9051016AAA 9061812AAA 9061819AAA 9061901AAA 9061902AAA 9061911AAA 9061912AAA 9061929AAA 9062018AAA 9062411AAA 9062412AAA 9062413AAA 9062508AAA 9062517AAA 9062519AAA 9062520AAA 9062702AAA 9072313AAA 9072314AAA 9072516AAA 9072601AAA 9080301AAA 9081307AAA 9081312AAA 9090930AAA 9090931AAA 9090956AAA 9091001AAA 9091002AAA 9093010AAA 9111222AAA 9111223AAA 9112013AAA 9121635AAA 9121711AAA 9121712AAA 9121713AAA 9121719AAA  Part Number: MC2-5070R Product: MAGEC 2 ROD, 5.0mm 70mmOFFSET Lot Numbers: 0011023AAA 0012101AAA 0012102AAA 0012128AAA 0012129AAA 0012201AAA 0012202AAA 0012910AAA 0012922AAA 0013001AAA 0013002AAA 8111511AAA 9022011AAA 9030412AAA 9030415AAA 9030504AAA 7080101AAA 7083002AAA 7090517AAA 7090608AAA 7090903AAA 7091514AAA 7091604AAA 7092101AAA 7100501AAA 7101310AAA 7112214AAA 7121218AAA 8030603AAA 8042406AAA 8042704AAA 9030205AAA 8043013AAA 8050804AAA 8052201AAA 8102504AAA 8102511AAA 8103001AAA 8103102AAA 8110621AAA 8110703AAA 9041817AAA 9041906AAA 9041918AAA 9050905AAA 9050907AAA 9062729AAA 9090517AAA 9090518AAA 9090609AAA 9093018AAA 9100115AAA 9100116AAA 9101501AAA 9101502AAA 9101514AAA 9101516AAA 9101516AAB 9101612AAA 9101613AAA 9101701AAA 9111310AAA 9112214AAA 9112216AAA 9122337AAA 9122338AAA 9122401AAA 9122709AAA  Part Number: MC2-5070S Product: MAGEC 2 ROD, 5.0mm 70mmSTANDARD Lot Numbers: 0010742AAA 0010743AAA 0010770AAA 0010771AAA 0010773AAA 0011643AAA 0011644AAA 0011714AAA 0011715AAA 0011803AAA 0011804AAA 0012003AAA 0012020AAA 0012024AAA 7080701AAA 7083001AAA 7090112AAA 7090516AAA 7090701AAA 7090902AAA 7091506AAA 7091603AAA 7092303AAA 7092605AAA 7092802AAA 7100409AAA 7101309AAA 7112003AAA 7112803AAA 7121410AAA 7121602AAA 8041114AAA 8042408AAA 8042705AAA 8050905AAA 8051004AAA 8051101AAA 8051107AAA 8051112AAA 8062821AAA 8071403AAA 8071601AAA 8071701AAA 8071902AAA 8072623AAA 8072626AAA 8080403AAA 8080613AAA 8091906AAA 8091909AAA 8100919AAA 8102313AAA 8102501AAA 8103117AAA 8103150AAA 8110501AAA 8110514AAA 8110915AAA 9030206AAA 9030207AAA 9042001AAA 9042002AAA 9042004AAA 9042209AAA 9042214AAA 9042216AAA 9050818AAA 9050909AAA 9051008AAA 9070807AAA 9070808AAA 9082301AAA 9082302AAA 9082613AAA 9082614AAA 9082701AAA 9082702AAA 9082704AAA 9090511AAA 9090512AAA 9090608AAA 9091301AAA 9091302AAA 9100117AAA 9100126AAA 9100301AAA 9100302AAA 9100705AAA 9101803AAA  Part Number: MC2-5090R Product: MAGEC 2 ROD, 5.0mm 90mmOFFSET Lot Numbers: 0010403AAA 0010404AAA 0011317AAA 0011318AAA 0011319AAA 0011401AAA 0011402AAA 0011506AAA 0011524AAA 0011525AAA 0011601AAA 0011602AAA 7081001AAA 7082502AAA 7083108AAA 7090110AAA 7090805AAA 7091602AAA 7092302AAA 7100401AAA 7102501AAA 7112002AAA 7112213AAA 7121411AAA 8020716AAA 8030601AAA 8042507AAA 8042804AAA 8062818AAA 8073105AAA 8091403AAA 8092702AAA 8092702AAB 8100818AAA 8101159AAA 8102314AAA 8103027AAA 8103050AAA 8112008AAA 8122112AAA 8122606AAA 9011103AAA 9022001AAA 9022114AAA 9031406AAA 9031414AAA 9042301AAA 9042305AAA 9042308AAA 9042308AAB 9042309AAA 9050902AAA 9060107AAA 9060604AAA 9060611AAA 9060614AAA 9061412AAA 9082216AAA 9082305AAA 9082306AAA 9082706AAA 9091201AAA 9091202AAA 9091317AAA 9091318AAA 9100333AAA 9100334AAA 9100407AAA 9100408AAA 9121402AAA  Part Number: MC2-5090S Product: MAGEC 2 ROD, 5.0mm 90mmSTANDARD Lot Numbers: 7072701AAA 7082501AAA 7083105AAA 7090111AAA 7090702AAA 7090806AAA 7091505AAA 7091601AAA 7092214AAA 7092301AAA 7092506AAA 7100219AAA 7101604AAA 7102419AAA 7110102AAA 7121217AAA 7121601AAA 8020207AAA 8040902AAA 8040917AAA 8042603AAA 8043003AAA 8050908AAA 8051003AAA 8051201AAA 8051402AAA 8051501AAA 8051511AAA 8051511AAB 8071032AAA 8071101AAA 8071105AAA 8071709AAA 8071801AAA 8072110AAA 8072421AAA 8072421AAB 8081610AAA 8081701AAA 8081714AAA 8081715AAA 8082002AAA 8082111AAA 8082805AAA 8082902AAA 8083006AAA 8090609AAA 8091801AAA 8091806AAA 8100403AAA 8102209AAA 8110104AAA 8110515AAA 8110601AAA 8111254AAA 8111901AAA 8112026AAA 8120903AAA 8120904AAA 8120905AAA 8121407AAA 8121915AAA 8121923AAA 8122007AAA 8122011AAA 9010801AAA 9011114AAA 9011816AAA 9011901AAA 9012301AAA 9021802AAA 9021807AAA 9021903AAA 9021906AAA 9021908AAA 9030521AAA 9030610AAA 9031409AAA 9040102AAA 9041005AAA 9041008AAA 9042401AAA 9042412AAA 9042414AAA 9042501AAA 9050819AAA 9052407AAA 9052408AAA 9052409AAA 9052804AAA 9052805AAA 9052816AAA 9052817AAA 9053025AAA 9053112AAA 9060105AAA 9061106AAA 9061120AAA 9061120AAB 9061310AAA 9082201AAA 9082202AAA 9082801AAA 9082802AAA 9101401AAA 9101403AAA 9101415AAA 9101416AAA 9101601AAA 9101610AAA 9110107AAA 9110108AAA 9110110AAA 9110401AAA 9110407AAA 9110408AAA 9110901AAA 9110902AAA 9110903AAA 9110904AAA 9111109AAA 9111110AAA 9112021AAA 9112022AAA 9112023AAA 9112101AAA 9112102AAA 9112611AAA  Part Number: MC2-5570R Product: MAGEC 2 ROD, 5.5mm 70mmOFFSET Lot Numbers: 8051804AAA 8052101AAA 8052105AAA 8052308AAA 8052309AAA 8060705AAA 8060723AAA 8060724AAA 8070303AAA 8071304AAA 8071316AAA 8072701AAA 8080705AAA 8080705AAB 8081408AAA 8081416AAA 8081511AAA 8081602AAA 8081713AAA 8092602AAA 8100811AAA 8102201AAA 8102212AAA 8102503AAA 8111908AAA 8112015AAA 8112112AAA 8122110AAA 8122607AAA 9021606AAA 9021607AAA 9022102AAA 9022814AAA 9030707AAA 9030810AAA 9040114AAA 9040201AAA 9052304AAA 9052316AAA 9052321AAA 9052406AAA 9060306AAA 9060309AAA 9060317AAA 9060703AAA 9060707AAA 9060714AAA 9060804AAA 9061006AAA 9061018AAA 9061032AAA 9061105AAA 9090444AAA 9091804AAA 9091805AAA 9121316AAA 9121317AAA  Part Number: MC2-5570S Product: MAGEC 2 ROD, 5.5mm 70mmSTANDARD Lot Numbers: 0012222AAA 0012301AAA 0012302AAA 0012304AAA 0012317AAA 0012318AAA 0012401AAA 0012415AAA 0012419AAA 0012713AAA 0012714AAA 0013115AAA 0013116AAA 8060103AAA 8060503AAA 8060611AAA 8060613AAA 8060702AAA 8061323AAA 8062017AAA 8062121AAA 8062124AAA 8062322AAA 8062628AAA 8062718AAA 8062905AAA 8063010AAA 8070502AAA 8082017AAA 8082022AAA 8082105AAA 8082201AAA 8082204AAA 8082213AAA 8083008AAA 8090401AAA 8092608AAA 8100809AAA 8101904AAA 8102306AAA 8102320AAA 8102323AAA 8102411AAA 8111603AAA 8121051AAA 8121056AAA 8121060AAA 8121330AAA 9011903AAA 9021502AAA 9021520AAA 9022605AAA 9021405AAA 9031410AAA 9031901AAA 9032810AAA 9032812AAA 9032814AAA 9052120AAA 9052121AAA 9052122AAA 9052209AAA 9052210AAA 9060413AAA 9060516AAA 9061224AAA 9061225AAA 9061314AAA 9062003AAA 9062004AAA 9062005AAA 9082001AAA 9082002AAA 9082933AAA 9083001AAA 9091019AAA 9091021AAA 9091116AAA 9121401AAA 9121437AAA 9122102AAA 9122603AAA  Part Number: MC2-5590R Product: MAGEC 2 ROD, 5.5mm 90mmOFFSET Lot Numbers: 0010335AAA 0010336AAA 0012801AAA 0012802AAA 0012829AAA 0012901AAA 8060107AAA 8060517AAA 8060605AAA 8060608AAA 8062019AAA 8062112AAA 8070505AAA 8071327AAA 8071402AAA 8071608AAA 8071711AAA 8071814AAA 8071910AAA 8072305AAA 8073006AAA 8080217AAA 8080809AAA 8081103AAA 8081104AAA 8082215AAA 8083003AAA 8090504AAA 8090724AAA 8091101AAA 8091211AAA 8091221AAA 8091311AAA 8091702AAA 8092415AAA 8092502AAA 8092505AAA 8100509AAA 9010919AAA 9012002AAA 9012125AAA 9012204AAA 9012425AAA 9021317AAA 9022110AAA 9022801AAA 9032511AAA 9032601AAA 9032603AAA 9032628AAA 9032633AAA 9051431AAA 9051501AAA 9051504AAA 9051506AAA 9051601AAA 9051602AAA 9051603AAA 9060408AAA 9060411AAA 9062106AAA 9062107AAA 9062403AAA 9062622AAA 9062623AAA 9073007AAA 9081401AAA 9081402AAA 9081412AAA 9081417AAA 9081601AAA 9112019AAA 9112020AAA 9122001AAA  Part Number: MC2-5590S Product: MAGEC 2 ROD, 5.5mm 90mmSTANDARD Lot Numbers: 0010620AAA 0010621AAA 8050118AAA 8050207AAA 8050312AAA 8050703AAA 8060109AAA 8061116AAA 8061126AAA 8061206AAA 8061210AAA 8062023AAA 8062113AAA 8062511AAA 8062702AAA 8062808AAA 8062920AAA 8070512AAA 8072309AAA 8072311AAA 8073005AAA 8080316AAA 8080401AAA 8080612AAA 8080812AAA 8080905AAA 8081316AAA 8081317AAA 8081404AAA 8081503AAA 8081703AAA 8082905AAA 8083101AAA 8090615AAA 8091103AAA 8092107AAA 8092405AAA 8092411AAA 8100101AAA 8100311AAA 8100414AAA 8101813AAA 8110105AAA 8110203AAA 8110223AAA 8111257AAA 8112604AAA 8112610AAA 8120619AAA 8120625AAA 8120722AAA 8121704AAA 8121705AAA 8121717AAA 8121801AAA 8121802AAA 9012003AAA 9012309AAA 9012332AAA 9012402AAA 9012402AAB 9012404AAA 9012410AAA 9022002AAA 9030612AAA 9030613AAA 9030703AAA 9030823AAA 9030826AAA 9030901AAA 9030902AAA 9030904AAA 9031102AAA 9032119AAA 9032120AAA 9032205AAA 9032212AAA 9032213AAA 9032217AAA 9032222AAA 9041701AAA 9041706AAA 9041707AAA 9050704AAA 9050706AAA 9050712AAA 9050806AAA 9051004AAA 9070915AAA 9070916AAA 9071111AAA 9071208AAA 9071209AAA 9071301AAA 9071302AAA 9071517AAA 9072315AAA 9072318AAA 9072319AAA 9072415AAA 9072420AAA 9072421AAA 9080812AAA 9080813AAA 9081301AAA 9081917AAA 9082601AAA 9082602AAA 9090410AAA 9091714AAA 9091801AAA 9111301AAA 9111302AAA 9111306AAA 9112119AAA 9112201AAA 9112209AAA 9112210AAA 9112211AAA 9112523AAA 9120306AAA 9120307AAA 9120401AAA 9121809AAA 9121810AAA 9121815AAA  Part Number: MC2-6070R Product: MAGEC 2 ROD, 6.0mm 70mmOFFSET Lot Numbers: 8041901AAA 8042002AAA 8042101AAA 8042304AAA 8042614AAA 8043008AAA 8051614AAA 8073109AAA 8082909AAA 8090604AAA 9081508AAA 9082707AAA 9112303AAA 9120511AAA 9120518AAA 9120531AAA 9120632AAA 9120633AAA 9121201AAA 9121202AAA 9122620AAA 9122621AAA  Part Number: MC2-6070S Product: MAGEC 2 ROD, 6.0mm 70mmSTANDARD Lot Numbers: 8041808AAA 8050203AAA 8050303AAA 8050401AAA 8051711AAA 8051715AAA 8062828AAA 8080101AAA 8080402AAA 8083007AAA 8092001AAA 8092012AAA 8092014AAA 9042611AAA 9061503AAA 9073115AAA 9091803AAA 9102401AAA 9120510AAA 9120517AAA 9120521AAA 9120526AAA 9120528AAA 9121203AAA 9122334AAA 9122602AAA  Part Number: MC2-6090R Product: MAGEC 2 ROD, 6.0mm 90mmOFFEST Lot Numbers: 0010401AAA 0010402AAA 8041646AAA 8043010AAA 8051105AAA 8051203AAA 8051205AAA 8051409AAA 8051503AAA 8051601AAA 8061303AAA 8071214AAA 8071219AAA 8080103AAA 8080112AAA 8080202AAA 8081508AAA 8090508AAA 8091011AAA 8092703AAA 8100533AAA 8121902AAA 8122106AAA 9011002AAA 9012209AAA 9012424AAA 9031821AAA 9051624AAA 9061510AAA 9072222AAA 9082004AAA 9092001AAA 9120414AAA 9120519AAA 9120901AAA 9121015AAA 9121309AAA  Part Number: MC2-6090S Product: MAGEC 2 ROD, 6.0mm 90mmSTANDARD Lot Numbers: 8041635AAA 8042102AAA 8042402AAA 8042404AAA 8042703AAA 8050808AAA 8071003AAA 8071005AAA 8071020AAA 8072007AAA 8072011AAA 8072103AAA 8072109AAA 8080105AAA 8080113AAA 8080605AAA 8081605AAA 8081611AAA 8082813AAA 8091704AAA 8091705AAA 8091706AAA 8091915AAA 8100314AAA 8120705AAA 8121805AAA 8121810AAA 9010807AAA 9021209AAA 9022526AAA 9022536AAA 9031113AAA 9031208AAA 9051101AAA 9051103AAA 9051104AAA 9071718AAA 9072424AAA 9100203AAA 9100204AAA 9100207AAA 9112301AAA 9120402AAA 9120416AAA 9120417AAA 9120501AAA 9120502AAA 9121009AAA 9121016AAA 9121439AAA 9121441AAA  Reference "Attachment 4 NuVasive MAGEC X PN-Lot Numbers.xlsx" uploaded into Associated Documents.  
Recalling Firm/
Manufacturer		 NuVasive Inc
7475 Lusk Blvd
San Diego CA 92121-5707
For Additional Information Contact Carol Bleakley, PhD
858-200-6993
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action The Recalling Firm sent an "URGENT FIELD SAFETY NOTICE" to customers via email and/or FedEx informing them that Post-implantation separation of an actuator end cap component has been observed and that separation of the end cap 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. The firm also informed customers that the long-term ability of a rod with a separated actuator end cap to continue to lengthen/distract is currently unknown. Distributors were contacted via email on 2/17/2020 Surgeons US were contacted via email and/or FedEx between 2/14/2020 to 2/18/2020. Surgeons OUS were contacted via email between 2/17/2020 to 2/21/2020. The Recalling Firm is recommending that surgeons perform routine clinical follow-up and discuss potential clinical implications and risks with patients who received affected products. The Recalling Firm is not recommending prophylactic revision based solely on the separation of an end cap. However, if an end cap separation is detected, removal of the device may be indicated. The decision to remove the device should be made by the physician in consultation with the patient and/or family. The Recalling Firm's Recommended User Action: -Immediately examine inventory to determine if they have product subject to this action on hand and quarantine the product. The Recalling Firm's representative will visit offices or contact customers directly to provide instructions for the return of the affected products. -Review, complete, sign and return the attached Consignee Confirmation Form accompanying the notification in accordance with the directions on the form. -Do not implant rods until further notice. -Review the details below and understand how to identify a separated end cap on postoperative XRay imaging: -Users should follow the appropriate postoperative procedure to assess the
Quantity in Commerce 3502 rods
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The Countries of Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Ireland, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Saudi Arabia, Slovenia/Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PGN and Original Applicant = NuVasive Specialized Orthopedics, Incorporated
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