Device recall
Z-0413-2018: Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers…
FDA device recall · Class II · Ormco/Sybronendo
Key facts
| Recall number (Z-number) | Z-0413-2018 |
|---|---|
| Recall event | 78861 |
| Product | Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and… |
| Product code | EKR |
| Recalling firm | Ormco/Sybronendo |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2024 |
| 510(k) numbers | K031664 |
| 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