Medical device recalls Moderate risk

Dentech Corp. recalls Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during de…

Recall date
April 21, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1676-2021
FDA classification
Class II
Brand / firm
Dentech Corp.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of CA, MN, KY, WA and the countries of Russia, Libya, Moldova, China, Egypt, India, Canada, Guatemala, Iraq, Saudi Araba, Australia, Ukraine, Israel, Indonesia, Malaysia, UK, Singapore, South Korea, Georgia, Taiwan Lithuania, Greece,…

Why it was recalled

Removing parts for safety reasons due to possible breakage.

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

What was recalled

Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.

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