Device 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 and different lengths for each diameter.
Z-2754-2016
Product summary
- Firm
- Anthogyr
- Event
- Event 74722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-2754-2016
Official wording
Reason: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Code information: Code OP28100 Size 02.8 x 10.0 Code OP28120 Size 02.8 x 12.0 Code OP28140 Size 02.8 x 14.0
Distribution pattern: US Distribution to sates of: NC, NY, and OR.
Derived failure modes
-
Unknown
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.