Reported Sep 11, 2019 · Terminated

DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

Coltene /Whaledent AG

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: Coltene /Whaledent AG · Feldwiesenstrasse 20 · Altstatten Sg, N/A · N/A

Is this the product you have?

  • DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Lot codes and dates
  • Lot/Batch Number J22952
Amount recalled
20 units of 5 burs/unit

Where it was sold

Why it was recalled

A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

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 Apr 30, 2021 · Data as of Sep 19, 6:54 PM UTC

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