Device recall
Z-1330-2014: Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number…
FDA device recall · Class II · Ormco/Sybronendo
Key facts
| Recall number (Z-number) | Z-1330-2014 |
|---|---|
| Recall event | 67849 |
| Product | Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment. |
| Product code | DYW |
| Recalling firm | Ormco/Sybronendo |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2014 |
| 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