Ormco/Sybronendo recalls Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugg

Recalled February 7, 2018 · FDA recall Z-0413-2018 · Ormco/Sybronendo

Hazard

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

Units

25,765 total

Sold at

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.

Description

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

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.

Manufacturer(s)

Ormco/Sybronendo

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →