# FDA recall Z-0413-2018

> **Ormco/Sybronendo** · Class II · device recall initiated 2017-12-27.

## 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).

## Distribution

USA (nationwide) distributed  to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.      Distributed internationally to Armenia, Australia, Canada, Chile, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Pakistan, Panama, Philippines, Singapore, South Korea, Switzerland, Thailand,  United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-0413-2018
- **Recalling firm:** Ormco/Sybronendo
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-27
- **Report date:** 2018-02-07
- **Termination date:** 2024-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glendora, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0413-2018

## Citation

> AI Analytics. FDA recall Z-0413-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0413-2018. Source: US FDA. Licensed CC0.

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