Device recall
Z-0527-2013: EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0527-2013 |
|---|---|
| Recall event | 63725 |
| Product | EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures. |
| Product code | KTT |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2013 |
| 510(k) numbers | K000083 |
| FEI number | 1825034 |
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