Device recall
Z-0953-04: Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal…
FDA device recall · Class III · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-0953-04 |
|---|---|
| Recall event | 28980 |
| Product | Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070 |
| Product code | GFF |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 3, 2012 |
| FEI number | 1045254 |
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