Device recall
Z-1204-2021: CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material…
FDA device recall · Class II · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Key facts
| Recall number (Z-number) | Z-1204-2021 |
|---|---|
| Recall event | 87251 |
| Product | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed… |
| Product code | KWQ |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000115331 |
At a glance
- None 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