FDA recall Z-0528-2022
NuVasive Specialized Orthopedics, Inc. · Class II · device
Product
MAGEC 1 System
Reason for recall
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
Distribution
Worldwide
Key facts
- Status
- Ongoing
- Initiation date
- 2019-06-25
- Report date
- 2022-02-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Aliso Viejo, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0528-2022