Drug recall
MAGEC 1 System
FDA recall event 89177 · Class II · NuVasive Specialized Orthopedics, Inc.
Key facts
| Event ID | 89177 |
|---|---|
| Recall numbers | Z-0528-2022 |
| Recalling firm | NuVasive Specialized Orthopedics, Inc. |
| Product type | Devices |
| Products | MAGEC 1 System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jun 25, 2019 |
| Report date | Feb 2, 2022 |
| City | Aliso Viejo |
| State | CA |
| Country | United States |
| FEI number | 3006179046 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: