Device recall
Z-0921-04: 955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts…
FDA device recall · Class III · Spinal Concepts, Inc
Key facts
| Recall number (Z-number) | Z-0921-04 |
|---|---|
| Recall event | 28488 |
| Product | 955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas |
| Product code | KWP |
| Recalling firm | Spinal Concepts, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 11, 2004 |
| 510(k) numbers | K983260 |
| FEI number | 3000718496 |
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