Medical device recalls Moderate risk

Coltene /Whaledent AG recalls DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

Recall date
July 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2436-2019
FDA classification
Class II
Brand / firm
Coltene /Whaledent AG
Sold / distributed
GA

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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