NUVASIVE MAGEC MAGEC 2 Rod — Class II medical device recall Z-0559-2023
Ongoing recall by NuVasive Specialized Orthopedics, Inc., reported 2022-12-21, distributed nationwide. During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a poten
| Recall number | Z-0559-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NuVasive Specialized Orthopedics, Inc., Aliso Viejo, CA, United States |
| Recall initiated | 2022-11-01 |
| Classified | 2022-12-14 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CL, IL, JO, NZ, SE, SG, TH |
| Quantity | 1,873 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00812258022600, 00812258022617, 00812258022624, 00812258022631, 00812258022648, 00812258022655, 00812258022662, 00812258022679, 00812258022686, 00812258022693, 00812258022709, 00812258022716 |
| Lot numbers | 0010301BAB, 0010333BAB, 0010335BAB, 0010335BAC, 0010336BAB, 0010403BAB, 0010404BAB, 0010404BAC, 0010620BAB, 0010620BAC, 0010621BAB, 0010742BAB, 0010743BAB, 0010770BAB, 0010771BAB, 0010773BAB, 0010818BAB, 0011023BAB, 0011317BAB, 0011317BAC, 0011318BAB, 0011319BAB, 0011319BAC, 0011401BAB, 0011402BAB, 0011402BAC, 0011506BAB, 0011524BAB, 0011525BAB, 0011525BAC, 0011601BAB, 0011602BAB, 0011643BAB, 0011644BAB, 0011714BAB, 0011715BAB, 0011803BAB, 0011804BAB, 0011804BAC, 0012003BAB and 460 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0559-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.