Device recall
Z-2095-2010: Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference…
FDA device recall · Class II · Medacta Usa Inc
Key facts
| Recall number (Z-number) | Z-2095-2010 |
|---|---|
| Recall event | 55465 |
| Product | Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral… |
| Product code | JWH |
| Recalling firm | Medacta Usa Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 29, 2012 |
| 510(k) numbers | K081023 |
| FEI number | 3006639916 |
At a glance
- 1–9 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