Device recall
Z-0559-2023: NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during…
FDA device recall · Class II · NuVasive Specialized Orthopedics, Inc.
Key facts
| Recall number (Z-number) | Z-0559-2023 |
|---|---|
| Recall event | 91125 |
| Product | 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 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard… |
| Product code | PGN |
| Recalling firm | NuVasive Specialized Orthopedics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201543 |
| FEI number | 3006179046 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database