FDA-Device2016-09-14Class II
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.
Anthogyr
Hazard
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Sold states
US Distribution to sates of: NC, NY, and OR.
Affected count
111 units
Manufactured in
2237 Avenue Andre Lasquin, Sallanches, France
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2753-2016Don't want to check this manually?
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