Device recall
Z-2850-2020: ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)
FDA device recall · Class II · Globus Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2850-2020 |
|---|---|
| Recall event | 86164 |
| Product | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile) |
| Product code | MAX |
| Recalling firm | Globus Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2021 |
| 510(k) numbers | K140411 |
| FEI number | 3004142400 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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