Device recall

Z-2753-2016: Axiom REG implants Sterile The Axiom REG implants are used as artificial root…

FDA device recall · Class II · Anthogyr

Key facts

Recall number (Z-number) Z-2753-2016
Recall event 74722
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 different lengths for…
Product code DZE
Recalling firm Anthogyr
Recall class Class II
Status Terminated
Termination date Mar 28, 2017
510(k) numbers K101913
FEI number 4224

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)