Device recall
Z-2302-2012: 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-2302-2012 |
|---|---|
| Recall event | 62801 |
| Product | 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along… |
| Product code | OIY |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 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