Device recall
Z-0120-2013: The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic…
FDA device recall · Class III · Ormco/Sybronendo
Key facts
| Recall number (Z-number) | Z-0120-2013 |
|---|---|
| Recall event | 63296 |
| Product | The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during… |
| Product code | EJF |
| Recalling firm | Ormco/Sybronendo |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 12, 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