Device recall
Z-1740-2011: UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development…
FDA device recall · Class II · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-1740-2011 |
|---|---|
| Recall event | 57705 |
| Product | UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the… |
| Product code | JWH |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2011 |
| 510(k) numbers | K060569 |
| 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