Ormco/Sybronendo: Medical Device Recall in 2018 - (Recall #: Z-0413-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 27, 2017

Date Posted: February 7, 2018

Recall Number: Z-0413-2018

Event ID: 78861

Reason for Recall:

Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).

Status: Terminated

Product Quantity: 25,765 total

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated