Medical device recalls Moderate risk

Meta C.G.M. Spa recalls REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

Recall date
April 26, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1777-2021
FDA classification
Class II
Brand / firm
Meta C.G.M. Spa
Sold / distributed
Distribution in US states of Texas and Florida

Why it was recalled

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

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

What was recalled

REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

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