Device recall
Z-1625-2011: Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone…
FDA device recall · Class II · Medtronic Spine LLC, formerly Kyphon Inc
Key facts
| Recall number (Z-number) | Z-1625-2011 |
|---|---|
| Recall event | 54384 |
| Product | Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine… |
| Product code | JDZ |
| Recalling firm | Medtronic Spine LLC, formerly Kyphon Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2011 |
| 510(k) numbers | K033801, K041584 |
| FEI number | 3004904811 |
At a glance
- 1–9 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