FDA Medical Device Recalls (openFDA)
Anthogyr: 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 each diameter.
- Recall number
- Z-2753-2016
- Recalling firm
- Anthogyr
- 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 each diameter.
- Status
- Terminated
- Initiated
- 2016-06-20
- Posted
- 2016-09-08
- Terminated
- 2017-03-28
- Reason
- Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
- 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: j.duthil@anthogyr.com 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: jduthil@anthogyr.com or mfoley@anthogyr.com.
- Quantity
- 111 units
- Distribution
- US Distribution to sates of: NC, NY, and OR.
- Lot, serial or model codes
- Code OP34080 Size 03.4 x 8.0 Code OP34100 Size 03.4 x 10.0 Code OP34120 Size 03.4 x 12.0 Code OP34140 Size 03.4 x 14.0 Code OP34160 Size 03.4 x 16.0 Code OP34180 Size 03.4 x 18.0 Code OP40060 Size 04.0 x 6.5 Code OP40080 Size 04.0 x 8.0 Code OP40100 Size 04.0 x 10.0 Code OP40120 Size 04.0 x 12.0 Code OP40140 Size 04.0 x 14.0 Code OP40160 Size 04.0 x 16.0 Code OP40180 Size 04.0 x 18.0 Code OP46060 Size 04.6 x 6.5 Code OP46080 Size 04.6 x 8.0 Code OP46100 Size 04.6 x 10 Code OP46120 Size 04.6 x 12 Code OP46140 Size 04.6 x 14 Code OP52060 Size 05.2 x 6.5 Code OP52080 Size 05.2 x 8.0 Code OP52100 Size 05.2 x 10.0 Code OP52120 Size 05.2 x 12.0 Code OP52140 Size 05.2 x 14.0
- 510(k) numbers
- ["K101913"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 4224
- Firm city
- Sallanches
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28