Device recall
Z-1508-2009: ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring…
FDA device recall · Class II · Ossur Engineering, Inc
Key facts
| Recall number (Z-number) | Z-1508-2009 |
|---|---|
| Recall event | 50706 |
| Product | ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. |
| Product code | HAX |
| Recalling firm | Ossur Engineering, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2010 |
| 510(k) numbers | K023959, K051918 |
| FEI number | 3002440200 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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