Device recall
Z-1873-2018: Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA device recall · Class II · Kelyniam Global, Inc.
Key facts
| Recall number (Z-number) | Z-1873-2018 |
|---|---|
| Recall event | 79791 |
| Product | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 |
| Product code | GXN |
| Recalling firm | Kelyniam Global, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2020 |
| 510(k) numbers | K103582 |
| FEI number | 3009424796 |
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