Recall archive / FDA device enforcement
NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of ... — FDA record Z-0559-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- NuVasive Specialized Orthopedics, Inc.
- Quantity
- 1,873 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0559-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 20818... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 21, 2022
- Recall initiation date
- Nov 1, 2022
- Center classification date
- Dec 14, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.