Recall Z-2753-2016 ยท DZE Implant, Endosseous, Root-Form
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.
| Date | Sep 8, 2016 (initiated Jun 20, 2016) |
| Status | Terminated |
| 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 |
| Quantity | 111 units |
| Distribution | US Distribution to sates of: NC, NY, and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM Anthogyr Sas, Mar 11, 2011 |