Device recall
Z-0325-2017: Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-0325-2017 |
|---|---|
| Recall event | 75214 |
| Product | Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant. |
| Product code | JWH |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2017 |
| 510(k) numbers | K160342 |
| FEI number | 1000116912 |
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