FDA Device recall Z-2754-2016
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth by Anthogyr, citing following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2754-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-20 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Anthogyr |
| Distribution | NC, NY, OR |
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.
Reason
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Identifiers
| code_info | Code OP28100 Size 02.8 x 10.0 Code OP28120 Size 02.8 x 12.0 Code OP28140 Size 02.8 x 14.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2754-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.