Device recall
Z-1993-2009: Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous…
FDA device recall · Class III · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-1993-2009 |
|---|---|
| Recall event | 52423 |
| Product | Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of… |
| Product code | JWH |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 11, 2010 |
| 510(k) numbers | K994370 |
| 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