Coltene Whaledent Inc recalls HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjun…

Recall date

June 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2422-2020

FDA classification

Class II

Brand / firm

Coltene Whaledent Inc

Sold / distributed

Pending

Why it was recalled

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

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

What was recalled

HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.