Device recall
Z-1136-2012: Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers…
FDA device recall · Class III · Ormco Corporation
Key facts
| Recall number (Z-number) | Z-1136-2012 |
|---|---|
| Recall event | 61221 |
| Product | Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment. |
| Product code | EJF |
| Recalling firm | Ormco Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 2, 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