Device recall
Z-1228-2010: 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular…
FDA device recall · Class II · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-1228-2010 |
|---|---|
| Recall event | 51926 |
| Product | 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and… |
| Product code | JWH |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2010 |
| 510(k) numbers | K031201 |
| FEI number | 3017298928 |
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