Device recall
Z-2963-2011: Heat Activated Niti Arches, Natural, Upper,.019x 25", Arch Wires. Packaged in…
FDA device recall · Class III · Highland Metals
Key facts
| Recall number (Z-number) | Z-2963-2011 |
|---|---|
| Recall event | 59349 |
| Product | Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth. |
| Product code | D |
| Recalling firm | Highland Metals |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 14, 2011 |
| FEI number | 1833132 |
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