Z-2754-2016Class II

Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of...

Name: Z-2754-2016 Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of...
Creator: Anthogyr
Published: 2016-06-20
License: https://open.fda.gov/license/

Anthogyr / initiated 2016-06-20 / Terminated / root cause: design

FDA source

Anthogyr began a recall of 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... on 2016-06-20. FDA classified it as Class II and gives the reason as "Following a FDA inspection showing that the firm failed to validate the design and process of its implants". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2754-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-20
Posted: 2016-09-08
Terminated: 2017-03-28
Recalling firm: Anthogyr
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.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Anthogyr, contacted physicians by phone and sent an " URGENT: MEDICAL DEVICE RECALL" notification by mail, dated 06/20/2016, informing users of a recall due to inadequate validation of design and process of implants by the FDA. The notice described the product, problem and actions to be taken. The physicians were instructed to isolate the parts and return any Anthogyr implants from lots subject to recall to Business Area Manager, 247 SouthWest 28th road, Miami, FL 33129;and complete and return the RETURN RESPONSE form by fax to: +33 (0)4 50 93 78 60 or e.mail: [email protected] or mail: Anthogyr- Director of Quality & Regulatory Affairs- 2237 avenue- Andre Lasquin-France. The firm stated that they will not market their products in the United States until they obtain validation through 21 CFR Part 820. If you have any questions, call 404-718-9689 or email: [email protected] or [email protected].
Quantity in commerce: 10 units
Distribution: US Distribution to sates of: NC, NY, and OR.
Product codes and lots: Code OP28100 Size 02.8 x 10.0 Code OP28120 Size 02.8 x 12.0 Code OP28140 Size 02.8 x 14.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2754-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2753-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2754-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code DZE

K141450Class IIAxiom 2.8Anthogyr Sas / cleared 2014-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)