Device recall
Z-1063-05: Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-1063-05 |
|---|---|
| Recall event | 32301 |
| Product | Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries. |
| Product code | MRA |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2007 |
| FEI number | 1000116912 |
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