Device recall
Z-1148-2012: AdvanSync is an orthodontic device intended for the orthodontic treatment of…
FDA device recall · Class II · Ormco Corporation
Key facts
| Recall number (Z-number) | Z-1148-2012 |
|---|---|
| Recall event | 60657 |
| Product | AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows: Part Number: 600-4000 (Kits-include 10 Right 600-4000 and 10 Left Assemblies). Lot Numbers: 070990588, 070976869… |
| Product code | DYJ |
| Recalling firm | Ormco Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 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