Device recall
Z-1696-2009: Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140…
FDA device recall · Class II · Smith & Nephew Inc
Key facts
| Recall number (Z-number) | Z-1696-2009 |
|---|---|
| Recall event | 52228 |
| Product | Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distributed internationally only. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra. |
| Product code | LPQ |
| Recalling firm | Smith & Nephew Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2010 |
| PMA numbers | P900009 |
| FEI number | 1020279 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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