Medical device recalls Moderate risk

Biomet 3i, LLC recalls UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device…

Recall date
July 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2760-2015
FDA classification
Class II
Brand / firm
Biomet 3i, LLC
Sold / distributed
Worldwide Distribution including Italy and Uruguay.

Why it was recalled

MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.

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

What was recalled

UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.

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