Home › NUVASIVE SPECIALIZED ORTHOPEDICS, INC. › MAGEC® Spinal Bracing and Distraction System
MAGEC® Spinal Bracing and Distraction System
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. · Model RA002-5555SL70 · UDI-DI 00856719002152
PGN
Prescription
9
510(k) clearances
1,094
Adverse events
4
Recalls
13
Facilities
Description
Spinal bracing and distraction system, 5.5 mm standard rod with 70 mm actuator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-03 | Globus Medical, Inc. | Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm. |
| 2022-11-01 | NuVasive Specialized Orthopedics, Inc. | 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 |
| 2020-02-13 | NuVasive Inc | 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 compone |
| 2019-06-25 | NuVasive Specialized Orthopedics, Inc. | Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015. |
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