Device recall
Z-0916-2008: Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number…
FDA device recall · Class II · Ormco Corporation
Key facts
| Recall number (Z-number) | Z-0916-2008 |
|---|---|
| Recall event | 46380 |
| Product | Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740 |
| Product code | DYH |
| Recalling firm | Ormco Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2012 |
| 510(k) numbers | K061481 |
| 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