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NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of s
Recalled December 21, 2022 · FDA recall Z-0559-2023 · NuVasive Specialized Orthopedics
Hazard
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. · FDA Class II
Units
1,873 units
Sold at
Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.
Description
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.
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
Manufacturer(s)
NuVasive Specialized Orthopedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →