Device recall
Z-0200-2012: Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB…
FDA device recall · Class III · Ormco Corporation
Key facts
| Recall number (Z-number) | Z-0200-2012 |
|---|---|
| Recall event | 60118 |
| Product | Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed… |
| Product code | DYW |
| Recalling firm | Ormco Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 24, 2012 |
| 510(k) numbers | K943245 |
| FEI number | 2016150 |
At a glance
- 1–9 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