Device recall
Z-0650-2025: DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that…
FDA device recall · Class II · Folsom Metal Products, Inc.
Key facts
| Recall number (Z-number) | Z-0650-2025 |
|---|---|
| Recall event | 95476 |
| Product | DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar… |
| Product code | HAE |
| Recalling firm | Folsom Metal Products, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3006803588 |
At a glance
- None 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