PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 7, 2018 Initiated: December 27, 2017 #Z-0413-2018

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.

Reason for Recall

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

Details

Recalling Firm
Ormco/Sybronendo
Units Affected
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.
Location
Glendora, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ormco/Sybronendo. Units affected: 25,765 total.
Why was this product recalled?
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0413-2018.