Thommen Medical AG recalls impression coping, repositionable, short, screw-retained, PF 4.0

Recall date

January 24, 2024

Source

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

Recall number

Z-1322-2024

FDA classification

Class II

Brand / firm

Thommen Medical AG

Sold / distributed

US Nationwide distribution in the states of OH and KY.

Why it was recalled

The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.

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

What was recalled

impression coping, repositionable, short, screw-retained, PF 4.0