Reported Feb 12, 2020 · Terminated

Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

Jjgc Industria E Comercio De Materials Dentarios Sa

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: Jjgc Industria E Comercio De Materials Dentarios Sa · Av Juscelino Kubitschek De Oliveira · Curitiba, N/A · N/A

Is this the product you have?

  • Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Lot codes and dates
  • Lot WH723
Amount recalled
2

Where it was sold

Why it was recalled

The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".

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

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 1, 2021 · Data as of Sep 19, 5:37 PM UTC

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