Food, drugs, devices › Ormco/Sybronendo
Device recall: Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. I
FDA enforcement event 78861 is a device recall by Ormco/Sybronendo of Glendora, CA, initiated 27 Dec 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 29 Apr 2024. Initiation: voluntary: firm initiated. Ormco/Sybronendo has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ormco/Sybronendo, Glendora, CA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0413-2018 | 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… | 25,765 total | Class II | Terminated | 7 Feb 2018 |
Context
Other enforcement events for Ormco/Sybronendo
All 14 events for Ormco/Sybronendo
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Apr 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.