FDA Device recall Z-0413-2018
Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger by Ormco Sybronendo, citing buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0413-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-27 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ormco Sybronendo |
| Distribution | US |
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 coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.
Reason
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Identifiers
| code_info | Part Number for Elements Obturation Unit (EOU): 973-0322; and Part Numbers for the Buchanan Heat Pluggers: 952-0004, 95…Part Number for Elements Obturation Unit (EOU): 973-0322; and Part Numbers for the Buchanan Heat Pluggers: 952-0004, 952-0003, 952-0005, 952-0006, 952-0007, 952-0031, 973-0219 (hot pulp test tip). All serial numbers of the EOU and respective Buchanan Heat Pluggers are included in the recall. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0413-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.