The Recall Desk

FDA (Devices) recall action 74722

Anthogyr recalled 2 products on 2016-09-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-09-14
Critical
0
Units
121

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-09-14

    Anthogyr Axiom REG Dental Implants Recalled for Design Validation Failure

    Anthogyr is recalling 111 units of Axiom REG dental implants because an FDA inspection found the firm failed to validate the design and process of the devices.

    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
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2016-09-14

    Anthogyr Recalls Axiom 2.8 Dental Implants Due to Design Validation Failure

    Anthogyr is recalling 10 units of Axiom 2.8 dental implants because an FDA inspection revealed the firm failed to validate the design and process of the devices.

    Product
    Axiom 2.8 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 an
    Category
    Distribution
    3 states