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[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 te

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductElements 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 coa
Brand / manufacturerOrmco/Sybronendo
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0413-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date27 December 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Ormco/Sybronendo

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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