Coltene Whaledent Inc recalls CEI Cutting Edge Instruments (PTC-57C)

Recall date

October 20, 2020

Source

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

Recall number

Z-0467-2021

FDA classification

Class II

Brand / firm

Coltene Whaledent Inc

Sold / distributed

Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

Why it was recalled

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

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

What was recalled

CEI Cutting Edge Instruments (PTC-57C)