Device recall
Z-0352-2018: Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB…
FDA device recall · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Recall number (Z-number) | Z-0352-2018 |
|---|---|
| Recall event | 78790 |
| Product | Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R |
| Product code | OAR |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2019 |
| FEI number | 1000477302 |
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