Device recall
Z-2280-2025: Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW…
FDA device recall · Class II · SPINEART SA
Key facts
| Recall number (Z-number) | Z-2280-2025 |
|---|---|
| Recall event | 97248 |
| Product | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW |
| Product code | NKB |
| Recalling firm | SPINEART SA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203506 |
| FEI number | 3007728266 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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