Device recall
Z-2355-2026: NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product…
FDA device recall · Class II · In2bones USA, LLC
Key facts
| Recall number (Z-number) | Z-2355-2026 |
|---|---|
| Recall event | 98978 |
| Product | NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090… |
| Product code | JDR |
| Recalling firm | In2bones USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161426 |
| FEI number | 3011580264 |
At a glance
- 1–9 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