Device recall
Z-1406-2021: Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in…
FDA device recall · Class II · Centinel Spine, Inc.
Key facts
| Recall number (Z-number) | Z-1406-2021 |
|---|---|
| Recall event | 87530 |
| Product | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S |
| Product code | MJO |
| Recalling firm | Centinel Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2021 |
| PMA numbers | P070001 |
| FEI number | 3007494564 |
At a glance
- None 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