Z-0413-2018Class II

Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal...

Name: Z-0413-2018 Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal...
Creator: Ormco/Sybronendo
Published: 2017-12-27
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2017-12-27 / Terminated

FDA source

Ormco/Sybronendo began a recall of 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... on 2017-12-27. FDA classified it as Class II and gives the reason as "Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0413-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-27
Posted: 2018-01-26
Terminated: 2024-04-29
Recalling firm: Ormco/Sybronendo
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.
Product code: EKR Plugger, Root Canal, Endodontic
Reason for recall: Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
FDA root cause: Under Investigation by firm
Action: Sybron Endo sent an Urgent: Medical Device Recall letter dated December 27, 2017. Customers were informed that Sybron Endo was still evaluating the root cause and would provide additional instructions once the root cause is determined. Distributors were asked to cease distributing any Elements Obturation Units (EOU), confirm if any are in inventory, return any affected devices, provide the notification to customers if further distributed, return any affected devices received from customers, and complete and return the acknowledgement form. Customers were instructed to examine current inventory for affected product, check the heat plugger to see if the NiTi icon appears and/or the tip turns glowing red, if it does do not use the heat plugger and return it to Sybron Endo, and complete and return the acknowledgement form. For further questions, please call the Customer Care department at (800) 537-7123.
Quantity in commerce: 25,765 total
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0413-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0413-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-26

Product code EKR

K031664Class IElements Obturation UnitSybron Endo/Analytic / cleared 2004-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)