Device recall
Z-1494-2011: Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L)…
FDA device recall · Class II · Pega Medical Inc.
Key facts
| Recall number (Z-number) | Z-1494-2011 |
|---|---|
| Recall event | 54620 |
| Product | Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation. |
| Product code | HSB |
| Recalling firm | Pega Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2011 |
| 510(k) numbers | K020885, K041393 |
| FEI number | 3000327445 |
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