Device recall
Z-0042-04: Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
FDA device recall · Class III · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-0042-04 |
|---|---|
| Recall event | 27300 |
| Product | Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. |
| Product code | JWH |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 11, 2003 |
| FEI number | 3017298928 |
At a glance
- None 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