Implant Direct Sybron Manufacturing, LLC recalls Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

Recall date

May 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2125-2017

FDA classification

Class II

Brand / firm

Implant Direct Sybron Manufacturing, LLC

Sold / distributed

Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan

Why it was recalled

Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

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

What was recalled

Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD