Drug recall
NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the…
FDA recall event 91125 · Class II · NuVasive Specialized Orthopedics, Inc.
Key facts
| Event ID | 91125 |
|---|---|
| Recall numbers | Z-0559-2023 |
| Recalling firm | NuVasive Specialized Orthopedics, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Nov 1, 2022 |
| Report date | Dec 21, 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: