Events

Recall of Device Recall Axiom REG Implants

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Anthogyr.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74722
  • Event Risk Class
    Class 2
  • Event Number
    Z-2753-2016
  • Event Initiated Date
    2016-06-20
  • Event Date Posted
    2016-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148291
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    Following a fda inspection showing that the firm failed to validate the design and process of its implants.
  • 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.

Device

Device Recall Axiom REG Implants
  • Model / Serial
    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
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to sates of: NC, NY, and OR.
  • Product Description
    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.
  • Manufacturer
    Anthogyr

Manufacturer

Anthogyr
  • Manufacturer Address
    Anthogyr, 2237 Avenue Andre Lasquin, Sallanches France
  • Source
    USFDA