Device recall
Z-1539-2008: 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-1539-2008 |
|---|---|
| Recall event | 46960 |
| Product | 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability. |
| Product code | JWH |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 2, 2008 |
| 510(k) numbers | K020114 |
| 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