FDA Device recall Z-0528-2022
MAGEC 1 System
- FDA Device
- Class II
- ongoing
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of MAGEC 1 System by Nuvasive Specialized Orthopedics, citing safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0528-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-06-25 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nuvasive Specialized Orthopedics |
| Distribution | n/a |
Product
MAGEC 1 System
Reason
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
Identifiers
| code_info | All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015. |
|---|
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-0528-2022%22
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