Medical device recalls Moderate risk

SICAT GMBH & CO. KG recalls SICAT IMPLANT V2.0

Recall date
July 15, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2951-2020
FDA classification
Class II
Brand / firm
SICAT GMBH & CO. KG
Sold / distributed
Worldwide distribution

Why it was recalled

A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

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

What was recalled

SICAT IMPLANT V2.0

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