Device recall
Z-2234-2024: Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm…
FDA device recall · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Recall number (Z-number) | Z-2234-2024 |
|---|---|
| Recall event | 94745 |
| Product | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade |
| Product code | GAD |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3012120772 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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