FDAJune 20, 2016device
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 f...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
What to do
FDA enforcement status: Terminated
Brands named
anthogyr
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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