Anthogyr: Medical Device Recall in 2016 - (Recall #: Z-2754-2016)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2016.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: June 20, 2016
Date Posted: September 14, 2016
Recall Number: Z-2754-2016
Event ID: 74722
Reason for Recall:
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Status: Terminated
Product Quantity: 10 units
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.
Voluntary or Mandated:
Voluntary: Firm initiated