Device recall
Z-1213-2013: 3DKnee e+ Tibial Insert. The insert is used along with the other components that…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-1213-2013 |
|---|---|
| Recall event | 64859 |
| Product | 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System. |
| Product code | OIY |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 1, 2013 |
| 510(k) numbers | K091956 |
| FEI number | 1000116912 |
At a glance
- 1–9 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