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[Recalled] Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr. — The laser engraving of the product incorrectly identifies the 4.3 Tapered Guide… | FDA 2019-12-23

recall fda device brazil

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

Recall details

ProductNeodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Brand / manufacturerJjgc Industria E Comercio De Materials Dentarios Sa
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0924-2020
Country of noticeBrazil
Risk levelClass II
Hazard typerecall
Notice date23 December 2019
EAN / barcode07899878030041

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".

This Class II recall concerns device products distributed in Brazil 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 Jjgc Industria E Comercio De Materials Dentarios Sa

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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