Device recall
Z-2068-2020: DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2068-2020 |
|---|---|
| Recall event | 85485 |
| Product | DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the… |
| Product code | OAR |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2021 |
| FEI number | 1721504 |
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