Elements Obturation Unit — Class II medical device recall Z-0413-2018
Terminated recall by Ormco/Sybronendo, reported 2018-02-07, distributed nationwide. Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
| Recall number | Z-0413-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2017-12-27 |
| Classified | 2018-01-26 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2024-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, EC, GB, GT, HK, IN, JP, KR, MX, MY, NL, PA, PH, PK, SG, SV, TH, VN |
| Quantity | 25,765 total |
| Reason classes | device malfunction |
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 for recall
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0413-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.