Device recall
Z-1878-2017: uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is…
FDA device recall · Class II · Ulrich Medical USA Inc
Key facts
| Recall number (Z-number) | Z-1878-2017 |
|---|---|
| Recall event | 76740 |
| Product | uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease… |
| Product code | KWQ |
| Recalling firm | Ulrich Medical USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2017 |
| 510(k) numbers | K150666 |
| FEI number | 3005532635 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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