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Anthogyr recalls Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing t
Recalled September 14, 2016 · FDA recall Z-2753-2016 · Anthogyr
Hazard
Following a FDA inspection showing that the firm failed to validate the design and process of its implants. · FDA Class II
Units
111 units
Sold at
US Distribution to sates of: NC, NY, and OR.
Description
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Product
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.
Manufacturer(s)
Anthogyr
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →