Device recall
Z-0639-2012: TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and…
FDA device recall · Class II · Ormco Corporation
Key facts
| Recall number (Z-number) | Z-0639-2012 |
|---|---|
| Recall event | 60582 |
| Product | TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment. |
| Product code | DZC |
| Recalling firm | Ormco Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2012 |
| FEI number | 2016150 |
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