Medical device recalls Moderate risk

Bien Air Dental SA recalls Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Recall date
August 27, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2797-2015
FDA classification
Class II
Brand / firm
Bien Air Dental SA
Sold / distributed
Worldwide Distribution - US distribution to one distributor in FL.

Why it was recalled

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

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

What was recalled

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

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