Device recall
Z-2836-2016: Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress…
FDA device recall · Class II · Ormco/Sybronendo
Key facts
| Recall number (Z-number) | Z-2836-2016 |
|---|---|
| Recall event | 75114 |
| Product | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth. |
| Product code | KIF |
| Recalling firm | Ormco/Sybronendo |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2017 |
| 510(k) numbers | K010940 |
| 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