Axiom 2 — Class II medical device recall Z-2754-2016
Terminated recall by Anthogyr, reported 2016-09-14, distributed in NC, NY, OR. Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
| Recall number | Z-2754-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Anthogyr, Sallanches, France |
| Recall initiated | 2016-06-20 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-03-28 |
| Distributed | NC, NY, OR |
| Quantity | 10 units |
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 for recall
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2754-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.