Device recall
Z-2012-2008: Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument…
FDA device recall · Class II · EBI, L.P.
Key facts
| Recall number (Z-number) | Z-2012-2008 |
|---|---|
| Recall event | 48158 |
| Product | Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused… |
| Product code | FZY |
| Recalling firm | EBI, L.P. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2008 |
| FEI number | 2242816 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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