Anthogyr recalls Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing tee…

Recall date

June 20, 2016

Source

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

Recall number

Z-2753-2016

FDA classification

Class II

Brand / firm

Anthogyr

Sold / distributed

US Distribution to sates of: NC, NY, and OR.

Why it was recalled

Following a FDA inspection showing that the firm failed to validate the design and process of its implants.

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

What was recalled

Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.