Reported Feb 7, 2018 · Terminated

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

Ormco/Sybronendo

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ormco/Sybronendo · 1332 S Lone Hill Ave · Glendora, CA · 91740-5339

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.

Lot codes and dates: Part Number
for Elements Obturation Unit (EOU)973-0322; and Part
Numbers for the Buchanan Heat Pluggers952-0004, 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
Amount recalled: 25,765 total

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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