FDA Device recall Z-0559-2023
NUVASIVE MAGEC MAGEC 2 Rod
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of NUVASIVE MAGEC MAGEC 2 Rod by Nuvasive Specialized Orthopedics, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0559-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-01 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nuvasive Specialized Orthopedics |
| Distribution | US |
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.
Identifiers
| code_info | REF Model Numbers/NSO Item #/Product Description/UDI-DI Code: MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard…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 90625 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0559-2023%22
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