Device recall
Z-2164-2010: MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-2164-2010 |
|---|---|
| Recall event | 55605 |
| Product | MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts. |
| Product code | LXH |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2011 |
| FEI number | 1000116912 |
At a glance
- None 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